Is this your brand? Sign in to claim ownership.

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 27 of 34

Device	Model / Reference	Registries	Class	Status
TYSHAK NuCLEUS™	612093	FDA UDI	Class II	Active
Mini Ghost™	612566	FDA UDI	Class II	Active
G-Armor Stent®	614750	FDA UDI	Class III	Active
Mini Ghost™	612523	FDA UDI	Class II	Active
COEfficient™	611241	FDA UDI	Class III	Unknown
Mini Ghost™	612715	FDA UDI	Class II	Unknown
Z-Med™	611673	FDA UDI	Class II	Active
Pts-X™	613730	FDA UDI	Class II	Unknown
Z-Med Ii™	611735	FDA UDI	Class II	Active
Mini Ghost™	612659	FDA UDI	Class II	Unknown
CP Stent™	614531	FDA UDI	Class III	Active
Pts-X™	613742	FDA UDI	Class II	Active
Z-Med Ii™	611767	FDA UDI	Class II	Active
G-Armor Stent®	614814	FDA UDI	Class III	Active
Tyshak®	611527	FDA UDI	Class II	Active
Pts-X™	613752	FDA UDI	Class II	Unknown
TYSHAK NuCLEUS™	612075	FDA UDI	Class II	Active
CP Stent™	614557	FDA UDI	Class III	Active
Impact™	252120	FDA UDI	Class II	Active
Z-Med X™	618406	FDA UDI	Class II	Unknown
Bib®	614440	FDA UDI	Class II	Active
Tyshak®	611153	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612065	FDA UDI	Class II	Unknown
Compass ™	613976	FDA UDI	Class II	Active
Tyshak®	610686	FDA UDI	Class II	Unknown
Z-Med Ii X™	618733	FDA UDI	Class II	Active
G-Armor Stent®	614778	FDA UDI	Class III	Active
G-Armor Stent®	614786	FDA UDI	Class III	Active
Mini Ghost™	612536	FDA UDI	Class II	Active
Tyshak®	610691	FDA UDI	Class II	Active
Tyshak®	610546	FDA UDI	Class II	Active
Z-Med X™	618451	FDA UDI	Class II	Active
Micro-Access Elite®	613359	FDA UDI	Class II	Unknown
CP Stent™	614381	FDA UDI	Class III	Active
G-Armor Stent®	614791	FDA UDI	Class III	Active
Z-Med X™	618449	FDA UDI	Class II	Active
Tyshak®	610604	FDA UDI	Class II	Unknown
Z-Med™	611680	FDA UDI	Class II	Active
Mini Ghost™	612729	FDA UDI	Class II	Active
Tyshak®	610630	FDA UDI	Class II	Unknown
Tyshak®	610529	FDA UDI	Class II	Active
COEfficient™	611209	FDA UDI	Class III	Active
Impact™	254750	FDA UDI	Class II	Active
Compass ™	613960	FDA UDI	Class II	Active
Mini Ghost™	612705	FDA UDI	Class II	Active
B.braun	612136	FDA UDI	Class II	Active
G-Armor Stent®	614802	FDA UDI	Class III	Active
Tyshak Ii®	611926	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612087	FDA UDI	Class II	Unknown
Tyshak Ii®	611947	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.