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
K081221Substantially Equivalent

Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console

Levitronix, LLC, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081221 is the FDA 510(k) clearance record for LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE, a class II device, cleared for Levitronix, LLC on under FDA product code DWA (Control, Pump Speed, Cardiopulmonary Bypass). FDA records list 11 510(k) clearances for Levitronix, LLC, from to . As of , FDA records show no recalls naming K081221.

Clearance record

Decision date
Received
(50 days to decision)
Product code
DWA Control, Pump Speed, Cardiopulmonary Bypass
Regulation
21 CFR 870.4380
Device class
Class II
Review panel
Cardiovascular
Applicant
Levitronix, LLC 45 First Ave., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWA

Trailing 12 months

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

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