510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K770937Substantially Equivalent

Pump, Bypass, Pulsatile, Avco

Avco Medical Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770937 is the FDA 510(k) clearance record for PUMP, BYPASS, PULSATILE, AVCO, a class II device, cleared for Avco Medical Products on under FDA product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type). FDA records list 5 510(k) clearances for Avco Medical Products, from to . As of , FDA records show no recalls naming K770937.

Clearance record

Decision date
Received
(178 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
Avco Medical Products 803 N. Front St. Suite 3, Mchenry IL
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