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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 22 of 34

Device	Model / Reference	Registries	Class	Status
Z-Med Ii™	611706	FDA UDI	Class II	Active
CP Stent™	614359	FDA UDI	Class III	Active
Tyshak Ii®	611797	FDA UDI	Class II	Active
CP Stent™	614534	FDA UDI	Class III	Active
Tyshak X™	618344	FDA UDI	Class II	Unknown
CP Stent™	614490	FDA UDI	Class III	Active
CP Stent™	614358	FDA UDI	Class III	Active
Z-Med™	610460	FDA UDI	Class II	Active
Tyshak®	611562	FDA UDI	Class II	Active
Multi-Track™	615008	FDA UDI	Class II	Unknown
Tyshak X™	618305	FDA UDI	Class II	Unknown
Impact™	222750	FDA UDI	Class II	Active
Mini Ghost™	612666	FDA UDI	Class II	Unknown
Mini Ghost™	612558	FDA UDI	Class II	Unknown
Mini Ghost™	612734	FDA UDI	Class II	Unknown
CP Stent™	614499	FDA UDI	Class III	Active
Micro-Access Elite®	613373	FDA UDI	Class II	Unknown
Elite HV®	612905	FDA UDI	Class II	Active
Tyshak®	610517	FDA UDI	Class II	Unknown
Accel®	613901	FDA UDI	Class II	Active
Tyshak®	610521	FDA UDI	Class II	Active
Multi-Track™	615005	FDA UDI	Class II	Active
Tyshak®	610506	FDA UDI	Class II	Unknown
Bib®	614466	FDA UDI	Class II	Active
G-Armor Stent®	614726	FDA UDI	Class III	Active
Z-Med Ii X™	618713	FDA UDI	Class II	Unknown
Bib®	614445	FDA UDI	Class II	Active
Z-Med Ii™	611738	FDA UDI	Class II	Active
Z-Med X™	618440	FDA UDI	Class II	Active
CP Stent™	614488	FDA UDI	Class III	Active
Z-Med™	610239	FDA UDI	Class II	Active
Tyshak®	610507	FDA UDI	Class II	Active
Pts-X™	613723	FDA UDI	Class II	Active
Bib®	614406	FDA UDI	Class II	Active
Mini Ghost™	612750	FDA UDI	Class II	Unknown
Bib®	614458	FDA UDI	Class II	Active
Mini Ghost™	612697	FDA UDI	Class II	Unknown
Impact™	124750	FDA UDI	Class II	Active
Accel®	613904	FDA UDI	Class II	Active
Z-Med™	611696	FDA UDI	Class II	Unknown
CP Stent™	614338	FDA UDI	Class III	Active
Mini Ghost™	612521	FDA UDI	Class II	Unknown
G-Armor Stent®	614812	FDA UDI	Class III	Active
Mini Ghost™	612550	FDA UDI	Class II	Unknown
Bib®	614435	FDA UDI	Class II	Active
Mini Ghost™	612682	FDA UDI	Class II	Active
CP Stent™	614500	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612071	FDA UDI	Class II	Unknown
Z-Med Ii X™	618720	FDA UDI	Class II	Active
Tyshak®	611419	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.