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510(k) K023174

DISPOSABLE TEMPORARY PACING WIRE by River Medical, Inc. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2003
Date Received
September 23, 2002
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 River Medical, Inc.

  • K944351 — SMARTDOSE IV PREFILLED INFUSION CONTAINER (November 15, 1995)
  • K944352 — SMARTDOSE III INFUSION CONTAINER (November 15, 1995)
  • K945298 — SMARTFLOW I ADMINISTRATION SET (June 14, 1995)
  • K943692 — SMART DOSE(TM) (April 28, 1995)
  • K932895 — RIVER PUMP (March 31, 1994)
  • K933335 — RIVER VIAL ADAPTER (March 1, 1994)
  • K915120 — TEF/PLATINUM PISTON (December 27, 1991)
  • K915121 — TEF/WIRE PISTON (December 23, 1991)
  • K913286 — H/A TOTAL-REGULAR, H/A TOTAL-OFFSET (December 18, 1991)
  • K913287 — H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET (December 18, 1991)

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)