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510(k) K850324

ELECATH OPEN TIP BIPOLAR PACING CATHETER by Electro-Catheter Corp. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1985
Date Received
January 28, 1985
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 Electro-Catheter Corp.

  • K934785 — MULTIPACE (July 27, 1995)
  • K933450 — CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION (April 19, 1995)
  • K943257 — TIP DEFLECTOR (GENESIS) (April 19, 1995)
  • K933451 — OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION (April 19, 1995)
  • K934787 — SILICORE SEMI-FLOATER (February 24, 1995)
  • K874154 — ELECATH(R) TRANSESOPHAGEAL PACING CATHETER (April 29, 1988)
  • K854511 — ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET (February 10, 1986)
  • K854975 — ELECATH PULSATILE PERFUSION PUMP (January 15, 1986)
  • K850065 — ELECATH TORKFLOAT PACING PROBE (April 10, 1985)
  • K844682 — ELECATH CARDIAC OUTPUT COMPUTER (March 6, 1985)

Other clearances for product code LDF

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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)