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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 14 of 34

Device	Model / Reference	Registries	Class	Status
Multi-Track™	615002	FDA UDI	Class II	Active
Tyshak Ii®	611534	FDA UDI	Class II	Active
NuDEL	614574	FDA UDI	Class III	Active
Tyshak Ii®	611536	FDA UDI	Class II	Active
Micro-Access Elite®	613367	FDA UDI	Class II	Unknown
Z-Med Ii X™	618729	FDA UDI	Class II	Active
NuDEL	614583	FDA UDI	Class III	Active
CP Stent™	614523	FDA UDI	Class III	Active
CP Stent™	614342	FDA UDI	Class III	Active
Tyshak Ii®	611538	FDA UDI	Class II	Active
Z-Med X™	618443	FDA UDI	Class II	Active
NuCLEUS-X™	612032	FDA UDI	Class II	Active
Tyshak®	610624	FDA UDI	Class II	Unknown
Tyshak Ii®	611794	FDA UDI	Class II	Active
G-Armor Stent®	614723	FDA UDI	Class III	Active
Compass ™	613969	FDA UDI	Class II	Active
TYSHAK Mini®	612014	FDA UDI	Class II	Active
Mini Ghost™	612565	FDA UDI	Class II	Active
Tyshak®	610551	FDA UDI	Class II	Active
CP Stent™	614511	FDA UDI	Class III	Active
G-Armor Stent®	614813	FDA UDI	Class III	Active
CP Stent™	614532	FDA UDI	Class III	Active
Tyshak Ii®	611920	FDA UDI	Class II	Active
Seamless™	614702	FDA UDI	Class I	Active
Z-Med Ii X™	618740	FDA UDI	Class II	Active
Tyshak®	611563	FDA UDI	Class II	Unknown
Accel®	613913	FDA UDI	Class II	Active
NuDEL	614585	FDA UDI	Class III	Active
Accel®	612145	FDA UDI	Class II	Active
Z-Med Ii™	611764	FDA UDI	Class II	Active
Z-Med™	611669	FDA UDI	Class II	Active
Bib®	614463	FDA UDI	Class II	Active
Z-Med Ii™	611712	FDA UDI	Class II	Active
Z-Med™	611671	FDA UDI	Class II	Active
Z-Med™	610457	FDA UDI	Class II	Active
Z-Med™	610455	FDA UDI	Class II	Unknown
B.braun	612152	FDA UDI	Class II	Active
NuCLEUS-X™	612036	FDA UDI	Class II	Active
G-Armor Stent®	614773	FDA UDI	Class III	Active
Accel™	613212	FDA UDI	Class I	Active
COEfficient™	611229	FDA UDI	Class III	Active
Multi-Track™	615003	FDA UDI	Class II	Active
Micro-Access Elite®	613358	FDA UDI	Class II	Unknown
Multi-Snare®	612970	FDA UDI	Class II	Unknown
Z-Med Ii X™	618710	FDA UDI	Class II	Active
COEfficient™	611232	FDA UDI	Class III	Unknown
Z-Med X™	618433	FDA UDI	Class II	Active
G-Armor Stent®	614797	FDA UDI	Class III	Active
G-Armor Stent®	614720	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612092	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.