Home / 510(k) Clearances / K110891

510(k) K110891

THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLUSIVE MODELING CATHETER by LeMaitre Vascular, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2011
Date Received
March 30, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by LeMaitre Vascular, Inc.

  • K212894 — PhasTIPP (March 31, 2022)
  • 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)

Other clearances for product code DQY

  • K260499 — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- (March 13, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K252417 — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (December 17, 2025)
  • K252390 — Telescope Guide Extension Catheter (October 29, 2025)
  • K250147 — CPS Locator 3D Delivery Catheter (August 22, 2025)
  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)