Medcomp C.A.V.H. Catheter

510(k) Number

K862771 ↗

FDA Product Code

LFK

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Duo Flow Catheter-Mc 54

  Class II

  FDA 510(k) K842416 Active Cleared 26 Jul 1984

• MCSCP8PS with 'y' Hub

  Class II

  FDA 510(k) K821684 Active Cleared 24 Jun 1982

• Twin Silicone Catheter

  Class II

  FDA 510(k) K923691 Active Cleared 25 Sep 1995

• Medicomp Flexi-Smooth Wound Drainage Catheter

  Class I

  FDA 510(k) K960426 Active Cleared 21 Mar 1996

• 1.9F X 20cm Vascu-Picc 1.9F X 50cm Vascu-Picc

  Class II

  FDA 510(k) K120980 Active Cleared 2 May 2012

• Double Lumen Sublcavian-Femoral

  Class II

  FDA 510(k) K841530 Active Cleared 25 Jun 1984

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• What is the Medcomp C.A.V.H. Catheter used for?

  The Medcomp C.A.V.H. Catheter is intended for use in gastroenterology and urology applications, as indicated by its advisory committee classification and openFDA medical specialty description, which specify Gastroenterology and Urology as the relevant medical specialties for this femoral catheter.

• How is the Medcomp C.A.V.H. Catheter supplied and identified?

  The Medcomp C.A.V.H. Catheter is identified by the product code LFK and device name MEDCOMP C.A.V.H. CATHETER, manufactured by Medical Components, Inc. at 1499 Delp Dr., Harleysville, PA 19438, and is supplied as a finished device with FDA 510(k) clearance under K862771.

• What regulatory pathway was used for the Medcomp C.A.V.H. Catheter?

  The Medcomp C.A.V.H. Catheter received FDA 510(k) clearance through a traditional submission process, with application number K862771, and was determined to be substantially equivalent to a predicate device, resulting in a SESE decision code on August 6, 1986.