Home / 510(k) Clearances / K161249

510(k) K161249

Streamline 6495 Bipolar Temporary Myocardial Pacing Lead by Medtronic — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2016
Date Received
May 3, 2016
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

  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)
  • K251831 — Bio-Medicus Life Support Catheter and Introducer (January 15, 2026)
  • K253511 — Concerto Versa™ Detachable Coil (January 14, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)
  • K250199 — VitalFlow Console (May 20, 2025)
  • K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) (March 27, 2025)

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)