Elecath Open Tip Bipolar Pacing Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K850324 ↗

FDA Product Code

LDF

Device Class

Class II

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Multipace

  Class II

  FDA 510(k) K934785 Active Cleared 27 Jul 1995

• Elecath(R) Transesophageal Pacing Catheter

  Class II

  FDA 510(k) K874154 Active Cleared 29 Apr 1988

• Elecath Portal Vein/Biliary Drain Assm

  Class I

  FDA 510(k) K821488 Active Cleared 28 May 1982

• Elecath Heparin-Coated Catheters

  Class II

  FDA 510(k) K841615 Active Cleared 5 Jun 1984

• Elecath Infant Arterial & Venous Cannu

  Class II

  FDA 510(k) K842369 Active Cleared 27 Aug 1984

• Pacing Kit, Semi-Floating

  Class II

  FDA 510(k) K770018 Active Cleared 14 Jan 1977

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