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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 4 of 34

Device	Model / Reference	Registries	Class	Status
Mini Ghost™	613817	FDA UDI	Class II	Active
Tyshak®	610501	FDA UDI	Class II	Active
Tyshak Ii®	611791	FDA UDI	Class II	Active
Tyshak®	611151	FDA UDI	Class II	Unknown
CP Stent™	614502	FDA UDI	Class III	Active
Micro-Access Elite®	613372	FDA UDI	Class II	Unknown
Tyshak X™	618342	FDA UDI	Class II	Active
CP Stent™	614370	FDA UDI	Class III	Active
Tyshak®	610520	FDA UDI	Class II	Active
Tyshak®	610514	FDA UDI	Class II	Unknown
Bib®	614456	FDA UDI	Class II	Active
CP Stent™	614305	FDA UDI	Class III	Active
CP Stent™	614364	FDA UDI	Class III	Active
Z-5™	611200	FDA UDI	Class II	Active
CP Stent™	614340	FDA UDI	Class III	Active
NuCLEUS-X™	612025	FDA UDI	Class II	Active
Tyshak®	610679	FDA UDI	Class II	Active
Z-Med Ii X™	618741	FDA UDI	Class II	Active
Micro-Access Elite®	613366	FDA UDI	Class II	Unknown
Tyshak Ii®	611537	FDA UDI	Class II	Active
Accel®	613943	FDA UDI	Class I	Active
Mini Ghost™	612663	FDA UDI	Class II	Unknown
NuCLEUS-X™	612033	FDA UDI	Class II	Active
Tyshak X™	618300	FDA UDI	Class II	Active
Tyshak X™	618310	FDA UDI	Class II	Active
Elite HV®	612916	FDA UDI	Class II	Active
Mini Ghost™	612582	FDA UDI	Class II	Unknown
G-Armor Stent®	614732	FDA UDI	Class III	Active
Tyshak®	611558	FDA UDI	Class II	Unknown
NuCLEUS-X™	612028	FDA UDI	Class II	Active
G-Armor Stent®	614775	FDA UDI	Class III	Active
Micro-Access Elite®	613371	FDA UDI	Class II	Unknown
B.braun	613412	FDA UDI	Class II	Unknown
Z-Med™	611811	FDA UDI	Class II	Active
Z-Med Ii™	611761	FDA UDI	Class II	Active
Z-Med Ii™	611713	FDA UDI	Class II	Unknown
G-Armor Stent®	614764	FDA UDI	Class III	Active
Z-Med™	610442	FDA UDI	Class II	Active
CP Stent™	614360	FDA UDI	Class III	Active
Z-Med Ii™	611710	FDA UDI	Class II	Active
G-Armor Stent®	614731	FDA UDI	Class III	Active
CP Stent™	614481	FDA UDI	Class III	Active
Voluminous™	622513	FDA UDI	Class II	Active
Z-Med™	611677	FDA UDI	Class II	Active
Z-Med X™	618417	FDA UDI	Class II	Active
Mini Ghost™	612595	FDA UDI	Class II	Unknown
CP Stent™	614344	FDA UDI	Class III	Active
B.braun	612151	FDA UDI	Class II	Active
Z-Med Ii X™	618742	FDA UDI	Class II	Active
Mini Ghost™	613825	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.