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FDA 510(k)

VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER

K-Number: K010485 · 2001-05-18

ApplicantBbraun
Decision Date2001-05-18
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Bbraun. It received FDA 510(k) clearance on 2001-05-18 under 510(k) number K010485. 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 VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER?

VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER is a medical device that received FDA 510(k) clearance on 2001-05-18. The listed applicant is Bbraun. The 510(k) number is K010485.

When did VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER receive FDA 510(k) clearance?

VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER received FDA 510(k) clearance on 2001-05-18, under 510(k) number K010485.

Who is the listed applicant for VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER?

The FDA 510(k) record lists Bbraun as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER?

The FDA product code for VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER is DTK.

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Related Devices (Code: DTK)

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.

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 KitBdK233680Celect 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 ApsK211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

Official Source

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