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FDA 510(k)

ALN OPTIONAL VANA CAVA FILTER

K-Number: K113124 · 2012-11-09

ApplicantAln Implants Chirurgicaux
Decision Date2012-11-09
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALN OPTIONAL VANA CAVA FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Aln Implants Chirurgicaux. It received FDA 510(k) clearance on 2012-11-09 under 510(k) number K113124. 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 ALN OPTIONAL VANA CAVA FILTER?

ALN OPTIONAL VANA CAVA FILTER is a medical device that received FDA 510(k) clearance on 2012-11-09. The listed applicant is Aln Implants Chirurgicaux. The 510(k) number is K113124.

When did ALN OPTIONAL VANA CAVA FILTER receive FDA 510(k) clearance?

ALN OPTIONAL VANA CAVA FILTER received FDA 510(k) clearance on 2012-11-09, under 510(k) number K113124.

Who is the listed applicant for ALN OPTIONAL VANA CAVA FILTER?

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

What is the FDA product code for ALN OPTIONAL VANA CAVA FILTER?

The FDA product code for ALN OPTIONAL VANA CAVA FILTER is DTK.

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Other records listing Aln Implants Chirurgicaux as applicant

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.

K163699ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with HookK070514ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO

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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