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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 13 of 25

Device	Model / Reference	Registries	Class	Status
Angios Classic Angiographic Catheter	ANG1-0053	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG505-0103	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS106722GW	FDA UDI	Class II	Active
Occlutech Delivery Set III	98DL006	FDA UDI	Class II	Active
Adelante S	ASU0713B5	FDA UDI	Class II	Active
Adelante SafeSheath II	AS07023B5	FDA UDI	Class II	Active
Lead Adaptor	664403-302	FDA UDI	Class II	Active
Occlutech® Steerable Guiding Sheath	51GS014	FDA UDI	Class II	Unknown
Breezeway II® Delivery Sheath	BG070079180	FDA UDI	Class II	Active
Adelante Radial	ASR05025B5	FDA UDI	Class II	Active
Bis/Bis-17	BIS/BIS-17	FDA UDI	Class II	Active
Breezeway II® Plus Delivery Sheath	BG090079180L	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP12030P	FDA UDI	Class II	Active
Destino Twist Steerable Guiding Sheath	DST0704509TD	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DC127122	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0067	FDA UDI	Class II	Active
Valve Bypass Tool	A10VBT03B25	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0497	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS106750	FDA UDI	Class II	Active
Adelante Breezeway	AB083009	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG106-0111	FDA UDI	Class II	Active
Adelante Breezeway	AB081042GW	FDA UDI	Class II	Active
Adelante Radial	ASR05007NPB5	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0959	FDA UDI	Class II	Active
Adelante SafeSheath Ultra Lite	ASUP851318P	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS856117	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS127122GW	FDA UDI	Class II	Active
DiRex™ Steerable Sheath	M004DS20S0	FDA UDI	Class II	Active
Adelante SafeSheath II	AS06013B5	FDA UDI	Class II	Active
Adelante Sigma	ASG08023	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG1-0505	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP10030P	FDA UDI	Class II	Active
Adelante Sigma	ASG1001035	FDA UDI	Class II	Active
Atar D-R T2p	ATAR D-R T2P	FDA UDI	Class II	Unknown
Adelante Sigma	ASG12010W	FDA UDI	Class II	Active
Baylis Med Tech Passport Steerable Sheath	PSS0705509	FDA UDI	Class II	Active
TourGuide™ Steerable Sheath	TG0705517	FDA UDI	Class II	Active
Arrive™ Braided Transseptal Sheath	990061-055	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG5-0070	FDA UDI	Class II	Active
Adelante Sigma Plus	ASGP05010	FDA UDI	Class II	Active
Adelante Sigma	ASG05010P	FDA UDI	Class II	Active
Adelante S	ASU01013B5	FDA UDI	Class II	Active
Angios Classic Angiographic Convenience Kit	ETANG4-0342	FDA UDI	Class II	Unknown
DiRex™ Steerable Sheath	M004DS10S0	FDA UDI	Class II	Active
Xi.d-Rl™	XI.D-RL	FDA UDI	Class II	Unknown
Senovo Bi-Flex Steerable Guiding Sheath	454997	FDA UDI	Class II	Active
Destino Steerable Guiding Sheath	DS857117	FDA UDI	Class II	Active
Angios Classic Angiographic Catheter	ANG506-0311	FDA UDI	Class II	Active
Adelante Peel-Away Introducer Set	AP09530P	FDA UDI	Class II	Active
Adelante Radial	ASR04010B5	FDA UDI	Class II	Active

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Importers

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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.