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510(k) K002481

ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 by Zcv ,Inc. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2000
Date Received
August 14, 2000
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 Zcv ,Inc.

  • K010099 — ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER (February 1, 2001)
  • K002603 — ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER (January 8, 2001)
  • K003118 — Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 (December 20, 2000)
  • K991060 — ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 (April 6, 2000)
  • K990689 — ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 (September 3, 1999)

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  • K241199 — Rotatable Connector (5944RL) (January 23, 2025)
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  • 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)