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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 12 of 34

Device	Model / Reference	Registries	Class	Status
Tyshak®	610687	FDA UDI	Class II	Unknown
TYSHAK NuCLEUS™	612094	FDA UDI	Class II	Active
Bib®	614438	FDA UDI	Class II	Active
COEfficient™	611212	FDA UDI	Class III	Active
Z-Med Ii X™	618708	FDA UDI	Class II	Unknown
Tyshak®	610616	FDA UDI	Class II	Unknown
Accel®	613926	FDA UDI	Class I	Active
Mini Ghost™	612572	FDA UDI	Class II	Active
NuDEL	614572	FDA UDI	Class III	Active
Mini Ghost™	612692	FDA UDI	Class II	Unknown
Impact™	122120	FDA UDI	Class II	Unknown
Elite HV®	612808	FDA UDI	Class II	Active
Mini Ghost™	612551	FDA UDI	Class II	Active
G-Armor Stent®	614815	FDA UDI	Class III	Active
Z-Med Ii X™	618721	FDA UDI	Class II	Active
Z-Med Ii X™	618706	FDA UDI	Class II	Active
NuCLEUS-X™	612034	FDA UDI	Class II	Active
NuDEL	614588	FDA UDI	Class III	Active
Mini Ghost™	612542	FDA UDI	Class II	Active
Mini Ghost™	612590	FDA UDI	Class II	Unknown
CP Stent™	614334	FDA UDI	Class III	Active
Accel®	613927	FDA UDI	Class I	Active
Elite HV®	612907	FDA UDI	Class II	Active
G-Armor Stent®	614760	FDA UDI	Class III	Active
Celsite	5430100	FDA UDI	Class II	Active
Z-Med Ii™	611762	FDA UDI	Class II	Active
Elite HV®	612805	FDA UDI	Class II	Active
COEfficient™	611227	FDA UDI	Class III	Active
Pts®	613703	FDA UDI	Class II	Active
Mini Ghost™	612588	FDA UDI	Class II	Active
Tyshak Ii®	611789	FDA UDI	Class II	Active
Impact™	184750	FDA UDI	Class II	Active
Celsite	5433842	FDA UDI	Class II	Active
G-Armor Stent®	614747	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612064	FDA UDI	Class II	Active
CP Stent™	614333	FDA UDI	Class III	Active
Mini Ghost™	613849	FDA UDI	Class II	Active
Bib®	614399	FDA UDI	Class II	Active
Mini Ghost™	612742	FDA UDI	Class II	Active
Bib®	614624	FDA UDI	Class II	Active
Z-Med™	610498	FDA UDI	Class II	Active
Mini Ghost™	612718	FDA UDI	Class II	Unknown
Mini Ghost™	612676	FDA UDI	Class II	Unknown
Tyshak Ii®	611936	FDA UDI	Class II	Active
TYSHAK NuCLEUS™	612089	FDA UDI	Class II	Unknown
NuDEL	614564	FDA UDI	Class III	Active
Bib®	614405	FDA UDI	Class II	Active
CP Stent™	614494	FDA UDI	Class III	Active
Impact™	252750	FDA UDI	Class II	Active
Mini Ghost™	612654	FDA UDI	Class II	Unknown

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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.