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510(k) K173236

Sentry IVC Filter by Novate Medical , Ltd. — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2018
Date Received
October 5, 2017
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

Other clearances by Novate Medical , Ltd.

  • K181202 — Sentry IVC Filter (June 6, 2018)
  • K162875 — Sentry IVC filter (February 17, 2017)

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