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510(k) K962833

HARMAC TEMPORARY PACING CATHETER WITH BALLOON by Harmac Medical Products, Inc. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1997
Date Received
June 28, 1996
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 Harmac Medical Products, Inc.

  • K021916 — HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 (August 29, 2002)
  • K963335 — HARMAC BALLOON WEDGE PRESSURE CATHETER (October 16, 1997)
  • K962829 — HARMAC BALLOON ANGIOGRAPHIC CATHETER (October 16, 1997)
  • K963073 — HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET (August 14, 1997)
  • K963336 — HARMAC THERMODILUTION CATHETER (August 14, 1997)
  • K963074 — HARMAC QUADPOLAR MAPPING PACING CATHETER (June 25, 1997)
  • K950895 — HARMAC EXTENSION INFUSION SET (September 1, 1995)

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  • 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)