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510(k) K861409

SYNCARE TEMPORARY CARDIAC PACING WIRE by Gyneco, Inc. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1986
Date Received
April 15, 1986
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 Gyneco, Inc.

  • K853216 — MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 (April 2, 1986)
  • K852357 — GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP (July 5, 1985)
  • K843941 — ENDOCYTE (February 25, 1985)
  • K841275 — FINE NEEDLE ASPIRATION DEVICE (August 17, 1984)

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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)