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 5 of 34

Device	Model / Reference	Registries	Class	Status
Bib®	614454	FDA UDI	Class II	Active
Tyshak®	610629	FDA UDI	Class II	Active
Z-Med X™	618414	FDA UDI	Class II	Active
Mullins X™	618800	FDA UDI	Class II	Active
Compass ™	613949	FDA UDI	Class II	Active
Mini Ghost™	612704	FDA UDI	Class II	Unknown
Mini Ghost™	612714	FDA UDI	Class II	Unknown
B.braun	612153	FDA UDI	Class II	Active
Mini Ghost™	612567	FDA UDI	Class II	Active
Accel®	612131	FDA UDI	Class I	Active
Tyshak®	610612	FDA UDI	Class II	Active
Mini Ghost™	612738	FDA UDI	Class II	Active
Z-Med™	610454	FDA UDI	Class II	Unknown
Z-Med Ii X™	618718	FDA UDI	Class II	Unknown
COEfficient™	611216	FDA UDI	Class III	Active
Accel®	613910	FDA UDI	Class II	Active
Bib®	614411	FDA UDI	Class II	Active
Mini Ghost™	612725	FDA UDI	Class II	Active
Elite HV®	612810	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612079	FDA UDI	Class II	Unknown
Z-Med™	610237	FDA UDI	Class II	Active
G-Armor Stent®	614739	FDA UDI	Class III	Active
Compass ™	613947	FDA UDI	Class II	Active
Tyshak Ii®	611777	FDA UDI	Class II	Active
Z-Med™	610467	FDA UDI	Class II	Active
TYSHAK Mini®	611986	FDA UDI	Class II	Active
Tyshak Ii®	611914	FDA UDI	Class II	Active
Tyshak Ii®	611939	FDA UDI	Class II	Active
Seamless™	614820	FDA UDI	Class I	Active
COEfficient™	611249	FDA UDI	Class III	Unknown
COEfficient™	611219	FDA UDI	Class III	Active
Z-Med™	611809	FDA UDI	Class II	Active
Z-Med Ii™	611711	FDA UDI	Class II	Active
Z-Med™	610450	FDA UDI	Class II	Unknown
G-Armor Stent®	614788	FDA UDI	Class III	Active
Mini Ghost™	612527	FDA UDI	Class II	Active
Multi-Track™	615000A	FDA UDI	Class II	Active
Z-Med Ii™	611751	FDA UDI	Class II	Active
NuDEL	614580	FDA UDI	Class III	Active
Mini Ghost™	612711	FDA UDI	Class II	Unknown
Z-Med™	611814	FDA UDI	Class II	Active
CP Stent™	614552	FDA UDI	Class III	Active
TYSHAK Mini®	611985	FDA UDI	Class II	Active
Tyshak®	610515	FDA UDI	Class II	Unknown
Bib®	614637	FDA UDI	Class II	Active
Micro-Access Elite®	613344	FDA UDI	Class II	Unknown
Z-Med Ii™	611658	FDA UDI	Class II	Active
Elite HV®	612908	FDA UDI	Class II	Active
Accel®	613934	FDA UDI	Class I	Active
Celsite	5430101	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.