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510(k) K944957

TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 by Medtronic Blood Systems, Inc. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1995
Date Received
October 7, 1994
Clearance Type
Traditional
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 Blood Systems, Inc.

  • K944966 — UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 (July 14, 1995)
  • K893207 — CLOSED CHEST SUPPORT CIRCUIT (December 12, 1989)
  • K893678 — DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H (November 27, 1989)
  • K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (May 31, 1989)
  • K891230 — MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. (May 19, 1989)
  • K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (February 22, 1989)
  • K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (December 21, 1988)
  • K884244 — INTERSEPT* PREBYPASS FILTER (December 5, 1988)
  • K883439 — INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM (October 13, 1988)
  • K883086 — INTERSEPT*PREBYPASS FILTER (September 16, 1988)

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)