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B BRAUN INTERVENTIONAL SYSTEMS, INC

Last updated May 24, 2026

What B BRAUN INTERVENTIONAL SYSTEMS, INC makes

The company manufactures interventional cardiovascular and vascular devices, including cardiac valvuloplasty catheters for treating narrowed heart valves, bare-metal and stent-graft systems for aortic interventions, and peripheral angioplasty balloons for treating blocked arteries. Additional products include vascular catheter introduction sets, vascular ports and catheters for long-term access, and multi-purpose drainage catheters for abdominal or thoracic fluid management. Cardiac sizing catheters are also part of the portfolio, used to measure valve annulus dimensions before procedures.

The device portfolio spans FDA device classes, with Class I products for minimally invasive accessories, Class II for moderate-risk items like angioplasty balloons and vascular ports, and Class III for high-risk interventions such as aortic stents and valvuloplasty catheters. All listed devices are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The company is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: bbraun.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(877)836-2228
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 784259751

Catalogue (1693)

Page 21 of 34

Device	Model / Reference	Registries	Class	Status
Tyshak Ii®	611921	FDA UDI	Class II	Active
Tyshak®	610536	FDA UDI	Class II	Active
Bib®	614427	FDA UDI	Class II	Active
B.braun	613408	FDA UDI	Class II	Unknown
Tyshak X™	618306	FDA UDI	Class II	Active
Tyshak Ii®	611772	FDA UDI	Class II	Active
G-Armor Stent®	614718	FDA UDI	Class III	Active
Mini Ghost™	612755	FDA UDI	Class II	Unknown
Z-Med™	611670	FDA UDI	Class II	Active
G-Armor Stent®	614727	FDA UDI	Class III	Active
G-Armor Stent®	614816	FDA UDI	Class III	Active
Bib®	614464	FDA UDI	Class II	Active
Z-Med™	611806	FDA UDI	Class II	Active
Z-Med™	611695	FDA UDI	Class II	Active
Micro-Access Elite®	613343	FDA UDI	Class II	Unknown
Micro-Access Elite®	613352	FDA UDI	Class II	Unknown
B.braun	613407	FDA UDI	Class II	Unknown
CP Stent™	614457	FDA UDI	Class III	Active
Tyshak Ii®	611552	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612085	FDA UDI	Class II	Active
Bib®	614443	FDA UDI	Class II	Active
Accel™	613213	FDA UDI	Class I	Active
Z-Med Ii™	611655	FDA UDI	Class II	Active
COEfficient™	611206	FDA UDI	Class III	Active
Z-Med Ii X™	618739	FDA UDI	Class II	Active
Elite HV®	612915	FDA UDI	Class II	Active
Tyshak Ii®	611916	FDA UDI	Class II	Active
Tyshak®	610607	FDA UDI	Class II	Unknown
CP Stent™	614544	FDA UDI	Class III	Active
Tyshak®	610510	FDA UDI	Class II	Active
Tyshak Ii®	611795	FDA UDI	Class II	Active
G-Armor Stent®	614808	FDA UDI	Class III	Active
Z-Med Ii™	611702	FDA UDI	Class II	Unknown
Pts-X™	613749	FDA UDI	Class II	Active
Compass ™	613962	FDA UDI	Class II	Active
Compass ™	613975	FDA UDI	Class II	Active
Mini Ghost™	612547	FDA UDI	Class II	Active
CP Stent™	614323	FDA UDI	Class III	Active
G-Armor Stent®	614751	FDA UDI	Class III	Active
Tyshak®	610617	FDA UDI	Class II	Active
Tyshak®	610684	FDA UDI	Class II	Unknown
Mini Ghost™	612717	FDA UDI	Class II	Active
Tyshak®	611417	FDA UDI	Class II	Unknown
Tyshak®	611152	FDA UDI	Class II	Unknown
Z-Med™	610499	FDA UDI	Class II	Unknown
Pts-X™	613724	FDA UDI	Class II	Active
Tyshak X™	618315	FDA UDI	Class II	Active
CP Stent™	614543	FDA UDI	Class III	Active
Z-Med Ii™	611731	FDA UDI	Class II	Active
Z-Med Ii™	611804	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (4)

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

B. Braun Interventional Systems, Inc. has four recall records initiated between October 30, 2007, and June 16, 2015, all of which are marked as terminated. The recalls involved incorrect components in needle accessories for Celsite Access Ports, reports of polyurethane catheter disconnections, out-of-specification endotoxin test results for peelable sheaths, and compromised package sealing on Tyvek pouches, leaving one edge partially open.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 16, 2015	Z-2382-2015	—	terminated	The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Apr 13, 2011	Z-2671-2011	—	terminated	The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access Ports. Two winged Surecan needle sizes are provided in Celsite U.S. package configurations: 20G (PN 4058631) or 22G (PN 16006593A). A 20G or 22G needle
Jun 22, 2009	Z-1961-2009	—	terminated	B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided to recall all Celsite ports supplied with the affected catheter lot. To date, B. Braun Interventional Systems (US) has not received any reports of catheter dis
Oct 30, 2007	Z-0264-2008	—	terminated	Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.