510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133598Substantially Equivalent

Cardiohelp System

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

K133598 is the FDA 510(k) clearance record for CARDIOHELP SYSTEM, a class II device, cleared for Maquet Cardiopulmonary, AG on under FDA product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass). FDA records list 44 510(k) clearances for Maquet Cardiopulmonary, AG, from to . As of , FDA records show 9 recalls naming K133598.

Clearance record

Decision date
Received
(180 days to decision)
Product code
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation
21 CFR 870.4220
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 DTQ

Trailing 12 months

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

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