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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 7 of 34

Device	Model / Reference	Registries	Class	Status
CP Stent™	614496	FDA UDI	Class III	Active
Z-Med Ii™	611727	FDA UDI	Class II	Active
Mini Ghost™	612763	FDA UDI	Class II	Active
CP Stent™	614329	FDA UDI	Class III	Active
Bib®	614434	FDA UDI	Class II	Active
Pts-X™	613745	FDA UDI	Class II	Unknown
Z-Med X™	618415	FDA UDI	Class II	Active
G-Armor Stent®	614795	FDA UDI	Class III	Active
Accel®	613925	FDA UDI	Class II	Active
Tyshak®	610665	FDA UDI	Class II	Unknown
Z-Med X™	618413	FDA UDI	Class II	Unknown
COEfficient™	611248	FDA UDI	Class III	Active
Mini Ghost™	612754	FDA UDI	Class II	Unknown
Tyshak Ii®	611940	FDA UDI	Class II	Active
Mini Ghost™	612583	FDA UDI	Class II	Active
Celsite	5436946	FDA UDI	Class II	Active
Tyshak®	611481	FDA UDI	Class II	Unknown
G-Armor Stent®	614790	FDA UDI	Class III	Active
Mullins X™	618828	FDA UDI	Class II	Active
Z-Med Ii™	611744	FDA UDI	Class II	Active
Tyshak Ii®	611693	FDA UDI	Class II	Active
CP Stent™	614356	FDA UDI	Class III	Active
Mullins X™	618806	FDA UDI	Class II	Active
Z-Med™	611785	FDA UDI	Class II	Unknown
Accel®	613923	FDA UDI	Class II	Active
NuDEL	614560	FDA UDI	Class III	Active
Z-6™	611051	FDA UDI	Class II	Active
Z-Med X™	618432	FDA UDI	Class II	Active
Z-Med X™	618404	FDA UDI	Class II	Unknown
Celsite	5433750	FDA UDI	Class II	Active
Impact™	224120	FDA UDI	Class II	Active
Tyshak®	610549	FDA UDI	Class II	Unknown
Asept	622289	FDA UDI	Class II	Active
Vena Tech™	4439985	FDA UDI	Class II	Active
CP Stent™	614327	FDA UDI	Class III	Active
CP Stent™	614505	FDA UDI	Class III	Active
Elite HV®	612801	FDA UDI	Class II	Active
Z-Med Ii X™	618702	FDA UDI	Class II	Unknown
Mini Ghost™	612761	FDA UDI	Class II	Unknown
Micro-Access Elite®	613342	FDA UDI	Class II	Unknown
Micro-Access Elite®	613365	FDA UDI	Class II	Unknown
CP Stent™	614510	FDA UDI	Class III	Active
Z-Med X™	618439	FDA UDI	Class II	Active
COEfficient™	611228	FDA UDI	Class III	Active
Z-Med™	610459	FDA UDI	Class II	Active
Z-Med™	610470	FDA UDI	Class II	Active
Mini Ghost™	612509	FDA UDI	Class II	Active
G-Armor Stent®	614803	FDA UDI	Class III	Active
CP Stent™	614345	FDA UDI	Class III	Active
Z-Med Ii X™	618749	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.