Cleared Special

NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH

K141432 · Maquet Cardiopulmonary, AG · Cardiovascular
Jul 2014
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K141432 is an FDA 510(k) clearance for the NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Maquet Cardiopulmonary, AG (Rastatt De-Bw, DE). The FDA issued a Cleared decision on July 7, 2014, 38 days after receiving the submission on May 30, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K141432 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2014
Decision Date July 07, 2014
Days to Decision 38 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTN — Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4400

Similar Devices — DTN Reservoir, Blood, Cardiopulmonary Bypass

All 168
Inspire HCR and HCR DUAL cardiotomy reservoirs
K251783 · Sorin Group Italia S.R.L. · Dec 2025
Quantum Perfusion Hybrid System
K241206 · Spectrum Medical S.R.L. · Jul 2024
MVR? Venous Reservoir Bag 800 mL; MVR? Venous Reservoir Bag 1600 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 800 mL; MVR? Venous Reservoir Bag with Cortiva? BioActive Surface 1600 mL
K241053 · Medtronic Cardiac Surgery · May 2024
BMR 1900 PHISIO
K223361 · Sorin Group Italia S.R.L. · Jun 2023
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583 · Medtronic, Inc. · Mar 2017
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K161733 · Sorin Group Italia S.R.L. · Mar 2017