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510(k) K133243

OPTION ELITE VENA CAVA FILTER SYSTEM by Rex Medical, L.P. — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2013
Date Received
October 22, 2013
Clearance Type
Traditional
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

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  • K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (July 28, 2021)
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  • K181202 — Sentry IVC Filter (June 6, 2018)
  • K173236 — Sentry IVC Filter (February 22, 2018)
  • K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena (November 20, 2017)