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510(k) K212894

PhasTIPP by LeMaitre Vascular, Inc. — Product Code DWQ

K212894 is an FDA 510(k) premarket notification submitted by LeMaitre Vascular, Inc. for the device "PhasTIPP". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code DWQ (Stripper, Vein, External), a Class II device regulated under 21 CFR 870.4885. LeMaitre Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
September 10, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Vein, External
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type

Other clearances by LeMaitre Vascular, Inc.

  • K190882 — XenoSure Biologic Patch (February 13, 2020)
  • K190267 — EZE SIT Valvulotome (October 30, 2019)
  • K183513 — XenoSure Dura Biologic Patch (June 13, 2019)
  • K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid (November 16, 2018)
  • K173323 — AnastoClip GC Closure System (March 8, 2018)
  • K152833 — Pruitt F3-S Polyurethane Carotid Shunt (January 21, 2016)
  • K143454 — Pruitt F3-S Carotid Shunt (August 27, 2015)
  • K142660 — Antegrade LeMills Valvulotome (October 17, 2014)
  • K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (April 10, 2014)
  • K133026 — UNBALLOON NON-OCCLUSION MODELING CATHETER (December 31, 2013)

Other clearances for product code DWQ

  • K041453 — SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (July 22, 2004)
  • K032387 — TRIVEX SYSTEM (October 29, 2003)
  • K905528 — URESIL VALVE CUTTER (April 18, 1991)
  • K904507 — PILLING BRUSH VALVULOTOME (March 1, 1991)
  • K885046 — INSITUCAT VALVE STRIPPER (February 28, 1990)
  • K872157 — HALL VEIN STRIPPER (July 7, 1987)
  • K811910 — VEIN-TRAP TM (July 20, 1981)

FDA data resources