Home / 510(k) Clearances / K030201

510(k) K030201

MODIFICATION TO EXPORT ASPIRATION CATHETER by Medtronic Vascular — Product Code NFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2003
Date Received
January 21, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
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)
  • K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Cathet (June 30, 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)

Other clearances for product code NFA

  • K073523 — INTERCEPTOR PLUS CORONARY FILTER SYSTEMS (August 1, 2008)
  • K073563 — MODIFICATION TO PROXIS SYSTEM (January 31, 2008)
  • K063785 — SPIDERFX EMBOLIC PROTECTION DEVICE (January 19, 2007)
  • K062870 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 (October 20, 2006)
  • K060651 — PROXIS SYSTEM, MODEL EPS101 (September 13, 2006)
  • K052523 — PROXIS SYSTEM (September 7, 2006)
  • K062201 — SPIDERX EMBOLIC PROTECTION DEVICE (August 11, 2006)
  • K061332 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) (August 11, 2006)
  • K061772 — TRIACTIV FX EMBOLIC PROTECTION SYSTEM (July 11, 2006)
  • K053195 — SPIDERX EMBOLIC PROTECTION DEVICE (June 23, 2006)