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510(k) K163699

ALN 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 Hook by Aln Implants Chirurgicaux — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2017
Date Received
December 29, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
Review Panel
CV
Submission Type

Other clearances by Aln Implants Chirurgicaux

  • K113124 — ALN OPTIONAL VANA CAVA FILTER (November 9, 2012)
  • K070514 — ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPRO (January 30, 2008)

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