FDA 510(k)

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM

K-Number: K152765 · 2016-02-26

ApplicantB. Braun Interventional Systems, Inc.

Decision Date2016-02-26

Product CodeDTK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2016-02-26 under 510(k) number K152765. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is a medical device that received FDA 510(k) clearance on 2016-02-26. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K152765.

When did VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM receive FDA 510(k) clearance?

VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM received FDA 510(k) clearance on 2016-02-26, under 510(k) number K152765.

Who is the listed applicant for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

The FDA 510(k) record lists B. Braun Interventional Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM?

The FDA product code for VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM is DTK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05785676ALN OATF Vena Cava FilterCOMPLETED NCT05881798Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set StudyRECRUITING

Other records listing B. Braun Interventional Systems, Inc. as applicant

K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

Related Devices (Code: DTK)

K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc.K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc.K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBd K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterWilliam Cook Europe Aps K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.