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Medcomp Femoral Vein Catheter

by Medical Components, Inc. 510(k)

Active United States

510(k) K801967

Overview

The Medcomp Femoral Vein Catheter is a set, dialysis, single needle with uni-directional pump device classified under product code FIF and regulation number 876.5820. It is a Class II medical device intended for vascular access in dialysis procedures.

This device received FDA 510(k) clearance (K801967) on September 26, 1980, as substantially equivalent to a predicate device. It is supplied by Medical Components, Inc. and is intended for use in clinical settings requiring femoral vein access for dialysis, with no indication of sterility, single-use status, MRI safety, or storage conditions provided in the data.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801967 Date26 Sep 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
FIF
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Medcomp Femoral Vein Catheter used for?

    The Medcomp Femoral Vein Catheter is intended for vascular access in dialysis procedures, specifically as a set, dialysis, single needle with uni-directional pump device for femoral vein access in clinical settings requiring hemodialysis support.

  • How is the Medcomp Femoral Vein Catheter supplied and is it sterile or single-use?

    The device data does not specify sterility, single-use status, or storage conditions for the Medcomp Femoral Vein Catheter; therefore, no information about its supply format, sterility, or reuse limitations can be derived from the provided authorization details.

  • What regulatory pathway was used for the Medcomp Femoral Vein Catheter and when was it cleared?

    The Medcomp Femoral Vein Catheter received FDA 510(k) clearance through the traditional pathway on September 26, 1980, under K801967, as substantially equivalent to a predicate device classified under product code FIF and regulation 876.5820.