NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE— 510(k) K102919

Clearance details

Applicant

Maquet Cardiopulmonary, AG

Product code

Code DTN

Device class

Class 2

Regulation

21 CFR 870.4400

Advisory panel

Cardiovascular

Date received

2010-10-01

Decision date

2011-03-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hirrlingen, DE

• K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
• K241206 — Quantum Perfusion Hybrid System2024-07-18
• K241053 — MVR Venous Reservoir Bag 800 mL +3 more2024-05-15
• K223361 — BMR 1900 PHISIO2023-06-10
• K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface2017-03-17

• K150267 — QUADROX-i Adult/Small Adult Oxygenators; QUADROX-iD Adult Oxygenators2015-05-07
• K140569 — ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)2014-11-19
• K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH2014-07-07
• K133598 — CARDIOHELP SYSTEM2014-05-21
• K133265 — QUADROX-IR ADULT AND SMALL ADULT2013-11-12

Death

3

Total

3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1642-2023 — Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445Class II·Ongoing·Maquet Medical Systems USA·20230518
• Z-1661-2023 — Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445Class II·Ongoing·Maquet Medical Systems USA·20230518

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102919.