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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 16 of 34

Device	Model / Reference	Registries	Class	Status
Z-Med™	611674	FDA UDI	Class II	Active
CP Stent™	614341	FDA UDI	Class III	Active
Pts-X™	613739	FDA UDI	Class II	Active
CP Stent™	614355	FDA UDI	Class III	Active
Tyshak X™	618316	FDA UDI	Class II	Unknown
Bib®	614437	FDA UDI	Class II	Active
Tyshak®	611480	FDA UDI	Class II	Active
Tyshak X™	618304	FDA UDI	Class II	Unknown
CP Stent™	614519	FDA UDI	Class III	Active
CP Stent™	614555	FDA UDI	Class III	Active
Z-Med™	610453	FDA UDI	Class II	Unknown
Accel®	613922	FDA UDI	Class I	Active
Mini Ghost™	612675	FDA UDI	Class II	Unknown
Tyshak®	610511	FDA UDI	Class II	Unknown
Impact™	144750	FDA UDI	Class II	Active
Mini Ghost™	612760	FDA UDI	Class II	Unknown
Asept®	622280	FDA UDI	Class I	Active
Mini Ghost™	613856	FDA UDI	Class II	Unknown
Z-Med X™	618425	FDA UDI	Class II	Active
Mini Ghost™	612506	FDA UDI	Class II	Active
CP Stent™	614307	FDA UDI	Class III	Active
Mini Ghost™	612554	FDA UDI	Class II	Active
Bib®	614418	FDA UDI	Class II	Active
Compass ™	613965	FDA UDI	Class II	Active
Mini Ghost™	612702	FDA UDI	Class II	Unknown
Tyshak®	610674	FDA UDI	Class II	Unknown
Bib®	614407	FDA UDI	Class II	Active
D'vill™	612841	FDA UDI	Class II	Active
Tyshak Ii®	611778	FDA UDI	Class II	Active
Z-Med™	610465	FDA UDI	Class II	Active
Tyshak Ii®	611941	FDA UDI	Class II	Active
B.braun	612150	FDA UDI	Class II	Active
Z-Med X™	618426	FDA UDI	Class II	Active
Z-Med X™	618405	FDA UDI	Class II	Unknown
Tyshak®	610523	FDA UDI	Class II	Active
NuDEL	614573	FDA UDI	Class III	Active
Vena Tech	5010024	FDA UDI	Class II	Active
G-Armor Stent®	614761	FDA UDI	Class III	Active
G-Armor Stent®	614759	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612083	FDA UDI	Class II	Active
Z-Med Ii X™	618707	FDA UDI	Class II	Unknown
Tyshak®	610539	FDA UDI	Class II	Active
G-Armor Stent®	614715	FDA UDI	Class III	Active
Accel®	612144	FDA UDI	Class II	Active
Tyshak®	610656	FDA UDI	Class II	Unknown
Asept®	622286	FDA UDI	Class II	Active
Z-Med Ii X™	618723	FDA UDI	Class II	Active
NuDEL	614569	FDA UDI	Class III	Active
Tyshak X™	618328	FDA UDI	Class II	Active
Z-Med Ii™	611003	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.