510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102919Substantially Equivalent

Neonatal Venous Hardshell Cardiotomy Reservoir, Pediatric Venous Hardshell Carsiotomy Reservoir, Neonatal Venous Hardshe

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

K102919 is the FDA 510(k) clearance record for NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE, a class II device, cleared for Maquet Cardiopulmonary, AG on under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass). FDA records list 44 510(k) clearances for Maquet Cardiopulmonary, AG, from to . As of , FDA records show 2 recalls naming K102919.

Clearance record

Decision date
Received
(161 days to decision)
Product code
DTN Reservoir, Blood, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
Maquet Cardiopulmonary, AG Hechinger Strasse 38, Hirrlingen, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTN

Trailing 12 months
1 clearance under product code DTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260