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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 30 of 34

Device	Model / Reference	Registries	Class	Status
Mini Ghost™	612564	FDA UDI	Class II	Unknown
B.braun	612135	FDA UDI	Class II	Active
Celsite	5436725	FDA UDI	Class II	Active
CP Stent™	614503	FDA UDI	Class III	Active
TYSHAK Mini®	612011	FDA UDI	Class II	Active
Tyshak®	610609	FDA UDI	Class II	Unknown
Z-Med Ii™	611752	FDA UDI	Class II	Active
CP Stent™	614357	FDA UDI	Class III	Active
Z-Med™	610474	FDA UDI	Class II	Unknown
Tyshak X™	618312	FDA UDI	Class II	Unknown
Z-Med™	610491	FDA UDI	Class II	Active
CP Stent™	614378	FDA UDI	Class III	Active
Mini Ghost™	612578	FDA UDI	Class II	Active
G-Armor Stent®	614777	FDA UDI	Class III	Active
Bib®	614421	FDA UDI	Class II	Active
Z-Med X™	618452	FDA UDI	Class II	Active
Mini Ghost™	612510	FDA UDI	Class II	Unknown
Tyshak X™	618340	FDA UDI	Class II	Active
G-Armor Stent®	614730	FDA UDI	Class III	Active
CP Stent™	614309	FDA UDI	Class III	Active
NuCLEUS-X™	612038	FDA UDI	Class II	Active
Tyshak®	610525	FDA UDI	Class II	Active
Pts-X™	613734	FDA UDI	Class II	Unknown
G-Armor Stent®	614752	FDA UDI	Class III	Active
Tyshak Ii®	611779	FDA UDI	Class II	Active
Z-Med™	611786	FDA UDI	Class II	Active
Compass ™	613968	FDA UDI	Class II	Active
Micro-Access Elite®	613350	FDA UDI	Class II	Unknown
Z-Med Ii™	611770	FDA UDI	Class II	Active
Mini Ghost™	612526	FDA UDI	Class II	Active
Bib®	614429	FDA UDI	Class II	Active
Mini Ghost™	612651	FDA UDI	Class II	Unknown
NuCLEUS-X™	612026	FDA UDI	Class II	Active
Pts-X™	613741	FDA UDI	Class II	Unknown
Mini Ghost™	612686	FDA UDI	Class II	Unknown
TYSHAK NuCLEUS™	612086	FDA UDI	Class II	Active
Tyshak®	610631	FDA UDI	Class II	Active
Mini Ghost™	612502	FDA UDI	Class II	Unknown
Mini Ghost™	612587	FDA UDI	Class II	Unknown
TYSHAK NuCLEUS™	612084	FDA UDI	Class II	Unknown
COEfficient™	611235	FDA UDI	Class III	Unknown
Mini Ghost™	612683	FDA UDI	Class II	Unknown
Z-Med X™	618428	FDA UDI	Class II	Active
Bib®	614633	FDA UDI	Class II	Active
G-Armor Stent®	614784	FDA UDI	Class III	Active
TYSHAK Mini®	611992	FDA UDI	Class II	Active
Tyshak®	610513	FDA UDI	Class II	Active
Bib®	614638	FDA UDI	Class II	Active
Mini Ghost™	612689	FDA UDI	Class II	Active
COEfficient™	611690	FDA UDI	Class III	Active

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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.