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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 34 of 34

Device	Model / Reference	Registries	Class	Status
Micro-Access Elite®	613364	FDA UDI	Class II	Unknown
Compass ™	613971	FDA UDI	Class II	Active
Mini Ghost™	612514	FDA UDI	Class II	Active
Mini Ghost™	612501	FDA UDI	Class II	Active
COEfficient™	611204	FDA UDI	Class III	Active
Micro-Access Elite®	613341	FDA UDI	Class II	Unknown
G-Armor Stent®	614807	FDA UDI	Class III	Active
Mini Ghost™	612598	FDA UDI	Class II	Unknown
Z-Med™	611682	FDA UDI	Class II	Active
Bib®	614444	FDA UDI	Class II	Active
Z-Med Ii™	611734	FDA UDI	Class II	Unknown
Z-Med™	611684	FDA UDI	Class II	Active
Tyshak Ii®	611934	FDA UDI	Class II	Active
Pts-X™	613733	FDA UDI	Class II	Unknown
Bib®	614634	FDA UDI	Class II	Active
Accel®	613903	FDA UDI	Class I	Active
Impact™	184120	FDA UDI	Class II	Active
Z-Med™	610445	FDA UDI	Class II	Active
Z-Med™	611819	FDA UDI	Class II	Active
Bib®	614449	FDA UDI	Class II	Active
Compass ™	613964	FDA UDI	Class II	Active
Tyshak Ii®	611908	FDA UDI	Class II	Active
Z-Med Ii™	611730	FDA UDI	Class II	Active
Z-Med Ii™	611709	FDA UDI	Class II	Unknown
COEfficient™	611236	FDA UDI	Class III	Unknown
Accel™	613211	FDA UDI	Class I	Active
G-Armor Stent®	614768	FDA UDI	Class III	Active
CP Stent™	614377	FDA UDI	Class III	Active
TYSHAK NuCLEUS™	612066	FDA UDI	Class II	Unknown
Mini Ghost™	612508	FDA UDI	Class II	Active
CP Stent™	614348	FDA UDI	Class III	Active
Z-Med Ii X™	618715	FDA UDI	Class II	Active
G-Armor Stent®	614762	FDA UDI	Class III	Active
G-Armor Stent®	614783	FDA UDI	Class III	Active
CP Stent™	614541	FDA UDI	Class III	Active
Mini Ghost™	612669	FDA UDI	Class II	Unknown
Z-Med™	610475	FDA UDI	Class II	Active
CP Stent™	614484	FDA UDI	Class III	Active
Mini Ghost™	612658	FDA UDI	Class II	Unknown
Elite HV®	612904	FDA UDI	Class II	Active
Celsite Implantable Access Port Systems	K130576	FDA 510(k)	Class II	Active
SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters	K162625	FDA 510(k)	Class II	Active
Venatech Convertible Vena Cava Filter System	K152765	FDA 510(k)	Class II	Active

Related Companies

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.