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IBC Flopump Model 6000

by International Biophysics Corp. 510(k)

Active United States

510(k) K983272

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983272 Date24 Mar 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KFM
Device Class
Class II
Regulation
21 CFR Part 870.4360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IBC Flopump Model 6000 is a non-roller type blood pump designed for cardiopulmonary bypass procedures. It is classified as a blood pump under FDA product code KFM and operates within Class II regulatory controls, ensuring compliance with specialized safety standards for cardiovascular applications.

This device is intended for single-use in controlled clinical settings and has received FDA 510(k) clearance under K983272. Supplied sterile and intended for use in cardiopulmonary bypass systems, it adheres to regulatory requirements outlined in 21 CFR 870.4360. The device is manufactured by International Biophysics Corp. and distributed in compliance with FDA-mandated registration and listing.

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