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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 29 of 34

Device	Model / Reference	Registries	Class	Status
CP Stent™	614324	FDA UDI	Class III	Active
D'vill™	612842	FDA UDI	Class II	Active
Tyshak®	611156	FDA UDI	Class II	Active
CP Stent™	614478	FDA UDI	Class III	Active
Mullins X™	618803	FDA UDI	Class II	Active
Bib®	614627	FDA UDI	Class II	Active
Z-Med™	610468	FDA UDI	Class II	Active
Mini Ghost™	612732	FDA UDI	Class II	Active
Z-Med™	610487	FDA UDI	Class II	Active
Accel®	613918	FDA UDI	Class II	Active
Mini Ghost™	612671	FDA UDI	Class II	Unknown
Celsite	5433734	FDA UDI	Class II	Active
Bib®	614422	FDA UDI	Class II	Active
Accel®	613935	FDA UDI	Class I	Active
CP Stent™	614545	FDA UDI	Class III	Active
CP Stent™	614516	FDA UDI	Class III	Active
CP Stent™	614347	FDA UDI	Class III	Active
Z-Med Ii™	611657	FDA UDI	Class II	Active
Tyshak®	610671	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612081	FDA UDI	Class II	Unknown
Tyshak®	610602	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612114	FDA UDI	Class II	Active
Tyshak®	610660	FDA UDI	Class II	Active
Tyshak®	610621	FDA UDI	Class II	Unknown
Tyshak X™	618313	FDA UDI	Class II	Unknown
CP Stent™	614382	FDA UDI	Class III	Active
Mini Ghost™	612594	FDA UDI	Class II	Active
Mini Ghost™	612525	FDA UDI	Class II	Active
Pts®	613701	FDA UDI	Class II	Active
G-Armor Stent®	614779	FDA UDI	Class III	Active
CP Stent™	614362	FDA UDI	Class III	Active
Accel®	613942	FDA UDI	Class I	Active
Tyshak®	610683	FDA UDI	Class II	Unknown
Z-Med™	610466	FDA UDI	Class II	Active
Z-Med X™	618416	FDA UDI	Class II	Active
G-Armor Stent®	614787	FDA UDI	Class III	Active
Mini Ghost™	612652	FDA UDI	Class II	Unknown
Mini Ghost™	612568	FDA UDI	Class II	Active
Tyshak®	610509	FDA UDI	Class II	Active
Z-Med™	611818	FDA UDI	Class II	Active
Z-Med Ii™	611747	FDA UDI	Class II	Active
Z-Med Ii™	611749	FDA UDI	Class II	Active
Mini Ghost™	612596	FDA UDI	Class II	Unknown
TYSHAK NuCLEUS™	612082	FDA UDI	Class II	Unknown
CP Stent™	614492	FDA UDI	Class III	Active
Z-Med Ii X™	618703	FDA UDI	Class II	Unknown
Z-Med™	610444	FDA UDI	Class II	Active
G-Armor Stent®	614794	FDA UDI	Class III	Active
CP Stent™	614548	FDA UDI	Class III	Active
Z-Med Ii™	611758	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 (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.