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
K904556Substantially Equivalent

Mansfield Cardiac Assist Model 940(Tm) Iab

Boston Scientific Corporation, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904556 is the FDA 510(k) clearance record for MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB, a class I device, cleared for Boston Scientific Corp on under FDA product code IOL (Treadmill, Powered). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K904556.

Clearance record

Decision date
Received
(439 days to decision)
Product code
IOL Treadmill, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Boston Scientific Corp 2710 Orchard Pkwy., San Jose CA
Third party review
No

Clearances, product code IOL

Trailing 12 months

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

FDA records show no clearances under product code IOL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IOL, 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