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
K053025Substantially Equivalent

Jostra Hlm Tubing Set

MAQUET CARDIOPULMONARY GmbH, Fairfield IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053025 is the FDA 510(k) clearance record for JOSTRA HLM TUBING SET, a class II device, cleared for Maquet Cardiopulmonary, AG on under FDA product code DWE (Tubing, Pump, Cardiopulmonary Bypass). FDA records list 44 510(k) clearances for Maquet Cardiopulmonary, AG, from to . As of , FDA records show 2 recalls naming K053025.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DWE Tubing, Pump, Cardiopulmonary Bypass
Regulation
21 CFR 870.4390
Device class
Class II
Review panel
Cardiovascular
Applicant
Maquet Cardiopulmonary, AG P.O. Box 2042, Fairfield IA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DWE

Trailing 12 months

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

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