Home / 510(k) Clearances / K042190

510(k) K042190

MODEL 6416 TEMPORARY PACING LEAD SYSTEM by Medtronic Vascular — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2004
Date Received
August 12, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacemaker, Temporary
Device Class
Class II
Regulation Number
870.3680
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 LDF

  • K242863 — Bioptimal Bipolar Pacing Catheter (June 15, 2025)
  • K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) (May 15, 2025)
  • K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec (January 31, 2025)
  • K241199 — Rotatable Connector (5944RL) (January 23, 2025)
  • K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar T (January 17, 2025)
  • K232261 — TME Temporary Myocardial Electrode (April 26, 2024)
  • K190716 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipol (August 8, 2019)
  • K173923 — Temporary Cardiac Pacing Wire (August 2, 2018)
  • K171253 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipol (May 25, 2017)
  • K161873 — Pacel Flow Directed Pacing Catheter (November 22, 2016)