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510(k) K971775

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 by Cardiac Control Systems, Inc. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1997
Date Received
May 13, 1997
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 Cardiac Control Systems, Inc.

  • K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (May 15, 1995)
  • K950210 — CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (May 3, 1995)
  • K923868 — CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER (May 14, 1993)
  • K905824 — MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE (May 16, 1991)
  • K904941 — MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE (January 3, 1991)
  • K895110 — MAESTRO PACEMAKER TEST MAGNET (September 26, 1989)
  • K884023 — MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER (October 17, 1988)
  • K884024 — POLYSAFE(TM) IMPLANTABLE PACING LEAD (October 14, 1988)
  • K883015 — POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP (October 6, 1988)
  • K883016 — POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP (September 16, 1988)

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)