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Oscor Inc.

Last updated September 17, 2026

Information

Country: US
Address: 4875 Palm Harbor Blvd, PALM HARBOR, FL, 34683
Website: oscor.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(727)937-2511
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1035166
DUNS Number: 101835833

Catalogue (1244)

Page 22 of 25

Device	Model / Reference	Registries	Class	Status
Peel-away introducer set	DYNJINTROPL12	FDA UDI	Class II	Unknown
DiRex™ Steerable Sheath	M004DS100	FDA UDI	Class II	Active
Destino Reach Steerable Guiding Sheath	DCR1007750	FDA UDI	Class II	Active
Ligature sleeve	LS-18	FDA UDI	Class III	Active
Destino Steerable Guiding Sheath	DS106717	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter Kit	ANG3-0039	FDA UDI	Class II	Active
Xi.mdt™	XI.MDT	FDA UDI	Class II	Unknown
Peel-away introducer set	DYNJINTROP9	FDA UDI	Class II	Unknown
Tb	020017	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG5-0241	FDA UDI	Class II	Active
Adelante Sigma	ASG08010P	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ANG4-0038	FDA UDI	Class II	Unknown
Angios Classic Angiographic Catheter	ANG506-0024	FDA UDI	Class II	Active
Vv-Plug	VV-PLUG	FDA UDI	Class III	Active
Destino Steerable Guiding Sheath	DS856122	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC127117	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DS009	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROP8	FDA UDI	Class II	Unknown
Adelante Sigma	ASG05010W	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0799	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DCT1607150GW	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856717	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10516P	FDA UDI	Class II	Active
Peel-away introducer set	DYNJINTROP75	FDA UDI	Class II	Unknown
Adelante Breezeway	AB101073	FDA UDI	Class II	Active
Helios	HRHCK05110S	FDA UDI	Class II	Active
Temporary Myocardial Heartwire	TME 223 TS	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC856750GW	FDA UDI	Class II	Active
SafeSheath® II	667467-300	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10530P	FDA UDI	Class II	Active
Atar-Mdt2s-V	ATAR-MDT2S-V	FDA UDI	Class II	Unknown
Baylis Med Tech Passport Steerable Sheath	PSS0654509	FDA UDI	Class II	Active
Tb	020024	FDA UDI	Class II	Unknown
Adelante Breezeway	AB073009	FDA UDI	Class II	Active
Blv/Bis 4403	BLV/BIS 4403	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP11516P	FDA UDI	Class II	Active
SafeSheath® II	SSCL9	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0958	FDA UDI	Class II	Active
Breezeway II® Delivery Sheath	BG100079180	FDA UDI	Class II	Active
Valve Bypass Tool	A07VBT05B25	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0705509	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0654509	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0080	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST1207150	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DL010	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0049	FDA UDI	Class II	Active
Transvalvular Insertion Tool (TVI)	667612-300	FDA UDI	Class II	Active
Senovo Bi-Flex Steerable Guiding Sheath	454956	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST12010039	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG106-0112	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (39)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 22, 2021	Z-0646-2022	—	completed	There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Mar 10, 2021	Z-1329-2021	—	terminated	Potential for open seal on sterile product
Sep 26, 2018	Z-0391-2019	—	terminated	During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
Mar 31, 2017	Z-2340-2017	—	terminated	The Reusable Oscor ATAR extension cables could separate from the connector during use.
Mar 31, 2017	Z-2733-2017	—	terminated	The Reusable Oscor ATAR extension cables could separate from the connector during use.
Oct 5, 2016	Z-0813-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0802-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0815-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0819-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0798-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0801-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0797-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0812-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0791-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0794-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0806-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0805-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0804-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0807-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0799-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0810-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0809-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0792-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0816-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0796-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0790-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0793-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0817-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0800-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0814-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0795-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0818-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0803-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0811-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Oct 5, 2016	Z-0808-2017	—	terminated	Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Jul 25, 2012	Z-0165-2013	—	terminated	Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.
Jul 3, 2008	Z-0130-2009	—	terminated	Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.
Jan 29, 2008	Z-2333-2008	—	terminated	The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
Sep 13, 2005	Z-0345-06	—	terminated	Sheath size is larger than dilator size causing insertion difficulties.