Home / 510(k) Clearances / K230156

510(k) K230156

5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter by Medtronic Vascular — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2023
Date Received
January 19, 2023
Clearance Type
Special
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 Medtronic Vascular

  • K232570 — Steerant™ Super Stiff Guidewire (October 24, 2023)
  • K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (August 22, 2023)
  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K192296 — Medtronic 6F Taiga Guiding Catheter (September 20, 2019)
  • K182957 — Heli-FX EndoAnchor System (November 21, 2018)
  • K173515 — Admiral Xtreme (April 12, 2018)
  • K171866 — Sentrant Introducer Sheath with Hydrophilic Coating (December 20, 2017)
  • K170191 — SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excisi (June 16, 2017)
  • K171427 — Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (June 13, 2017)
  • K162097 — InTRAkit (November 17, 2016)

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)