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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 28 of 34

Device	Model / Reference	Registries	Class	Status
Bib®	614398	FDA UDI	Class II	Active
Z-Med Ii™	611754	FDA UDI	Class II	Active
Z-Med X™	618441	FDA UDI	Class II	Active
Z-Med Ii X™	618736	FDA UDI	Class II	Active
Bib®	614419	FDA UDI	Class II	Active
Mini Ghost™	612722	FDA UDI	Class II	Unknown
COEfficient™	611218	FDA UDI	Class III	Active
B.braun	613401	FDA UDI	Class II	Unknown
Mini Ghost™	612706	FDA UDI	Class II	Unknown
Tyshak Ii®	611943	FDA UDI	Class II	Active
Tyshak®	610685	FDA UDI	Class II	Unknown
Mini Ghost™	612532	FDA UDI	Class II	Active
CP Stent™	614525	FDA UDI	Class III	Active
CP Stent™	614350	FDA UDI	Class III	Active
Tyshak®	611161	FDA UDI	Class II	Unknown
Z-Med™	611477	FDA UDI	Class II	Unknown
Z-Med™	611816	FDA UDI	Class II	Active
Micro-Access Elite®	613345	FDA UDI	Class II	Unknown
Micro-Access Elite®	613363	FDA UDI	Class II	Unknown
Bib®	614430	FDA UDI	Class II	Active
G-Armor Stent®	614765	FDA UDI	Class III	Active
Z-Med™	610232	FDA UDI	Class II	Active
Mini Ghost™	612524	FDA UDI	Class II	Active
Tyshak®	610552	FDA UDI	Class II	Unknown
CP Stent™	614353	FDA UDI	Class III	Active
Z-Med™	611678	FDA UDI	Class II	Active
B.braun	613411	FDA UDI	Class II	Unknown
Z-Med Ii™	611760	FDA UDI	Class II	Active
Mini Ghost™	612699	FDA UDI	Class II	Unknown
Mini Ghost™	612723	FDA UDI	Class II	Unknown
Tyshak Ii®	611553	FDA UDI	Class II	Active
CP Stent™	614498	FDA UDI	Class III	Active
Mini Ghost™	612743	FDA UDI	Class II	Unknown
Compass ™	613950	FDA UDI	Class II	Active
Tyshak®	610522	FDA UDI	Class II	Active
Tyshak®	611416	FDA UDI	Class II	Active
TYSHAK Mini®	611991	FDA UDI	Class II	Active
Tyshak Ii®	611912	FDA UDI	Class II	Active
CP Stent™	614470	FDA UDI	Class III	Active
G-Armor Stent®	614745	FDA UDI	Class III	Active
CP Stent™	614506	FDA UDI	Class III	Active
Mini Ghost™	612665	FDA UDI	Class II	Active
Vena Tech	5010028	FDA UDI	Class II	Active
CP Stent™	614539	FDA UDI	Class III	Active
Micro-Access Elite®	613348	FDA UDI	Class II	Unknown
Elite HV®	612802	FDA UDI	Class II	Active
Tyshak®	611155	FDA UDI	Class II	Unknown
Mini Ghost™	612661	FDA UDI	Class II	Active
Tyshak Ii®	611927	FDA UDI	Class II	Active
Mini Ghost™	612576	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

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.