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510(k) K181202

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

K181202 is an FDA 510(k) premarket notification submitted by Novate Medical , Ltd. for the device "Sentry IVC Filter". The FDA issued a decision of Substantially Equivalent on June 6, 2018. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Novate Medical , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2018
Date Received
May 7, 2018
Clearance Type
Special
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.

  • K173236 — Sentry IVC Filter (February 22, 2018)
  • K162875 — Sentry IVC filter (February 17, 2017)

Other clearances for product code DTK

  • K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E) (September 10, 2024)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (July 31, 2024)
  • K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK (June 26, 2024)
  • K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (February 29, 2024)
  • K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM- (January 18, 2024)
  • K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (July 28, 2021)
  • K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (July 28, 2021)
  • K173236 — Sentry IVC Filter (February 22, 2018)
  • K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (November 20, 2017)
  • K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena (November 20, 2017)

FDA data resources