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510(k) K930069

BIPOLAR BALLOON PACING CATHETER BY J-LLOYD by J-Lloyd Medical, Inc. — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
January 6, 1993
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 J-Lloyd Medical, Inc.

  • K971504 — HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER (April 20, 1998)
  • K973639 — ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. (April 20, 1998)
  • K974336 — CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (February 13, 1998)
  • K974335 — EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. (February 13, 1998)
  • K963248 — FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) (February 3, 1997)
  • K950440 — DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (September 15, 1995)
  • K940547 — FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED (August 11, 1994)
  • K935405 — ARTERIAL EMBOLECTOMY (July 25, 1994)
  • K935403 — WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD (May 12, 1994)
  • K935404 — FLOW DIRECTED THERMODILUTION BALLOON CATHETER (May 3, 1994)

Other clearances for product code LDF

  • K242863 — Bioptimal Bipolar Pacing Catheter (June 15, 2025)
  • 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)