510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K972740Substantially Equivalent

Himex Centriflow Centrifugal Perfusion Pump System (Cfk01)

Himex Production Corp., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972740 is the FDA 510(k) clearance record for HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01), a class II device, cleared for Himex Production Corp. on under FDA product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type). FDA records list one 510(k) clearance for Himex Production Corp. As of , FDA records show no recalls naming K972740.

Clearance record

Decision date
Received
(199 days to decision)
Product code
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation
21 CFR 870.4360
Device class
Class II
Review panel
Cardiovascular
Applicant
Himex Production Corp. Medical Towers Bldg, Houston TX
510(k) summary
Summary
Third party review
No

Clearances, product code KFM

Trailing 12 months

FDA records hold no clearances under product code KFM in the trailing twelve months.

FDA records show no clearances under product code KFM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KFM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260