510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130300Substantially Equivalent

Heater-Cooler Unit Hcu 40

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

K130300 is the FDA 510(k) clearance record for HEATER-COOLER UNIT HCU 40, a class II device, cleared for Maquet Cardiopulmonary, AG on under FDA product code DWC (Controller, Temperature, Cardiopulmonary Bypass). FDA's definition for product code DWC reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 44 510(k) clearances for Maquet Cardiopulmonary, AG, from to . As of , FDA records show no recalls naming K130300.

Clearance record

Decision date
Received
(144 days to decision)
Product code
DWC Controller, Temperature, Cardiopulmonary Bypass
Regulation
21 CFR 870.4250
Device class
Class II
Review panel
Cardiovascular
Applicant
Maquet Cardiopulmonary, AG 45 Barbour Pond Dr., Wayne NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DWC

Trailing 12 months

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

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