KFM · Class II · 21 CFR 870.4360

FDA Product Code KFM: Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

Leading manufacturers include Terumo Cardiovascular Systems Corporation and Cardiacassist, Inc..

2
Total
2
Cleared
344d
Avg days
2021
Since

List of Pump, Blood, Cardiopulmonary Bypass, Non-roller Type devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Aug 03, 2023
LifeSPARC System
K232132
Cardiacassist, Inc.
Cardiovascular · 16d
Cleared Nov 18, 2021
Capiox iCP Centrifugal Pump
K200091
Terumo Cardiovascular Systems Corporation
Cardiovascular · 672d

How to use this database

This page lists all FDA 510(k) submissions for Pump, Blood, Cardiopulmonary Bypass, Non-roller Type devices (product code KFM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →