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510(k) K143405

Option (TM) ELITE Vena Cava Filter 100cm System by Rex Medical, L.P. — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2015
Date Received
November 28, 2014
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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  • K060904 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM (April 28, 2006)
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  • K181202 — Sentry IVC Filter (June 6, 2018)
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