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

Reservoir, Blood, Cardiopulmonary Bypass

MAQUET CARDIOPULMONARY AG

The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy Reservior, Neonatal Venous Hardhsh.

Pre-market Notification Details

• Device ID: K141432
• 510k Number: K141432
• Device Name: NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
• Classification: Reservoir, Blood, Cardiopulmonary Bypass
• Applicant: MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437
• Contact: Katrin Schwenkglenks
• Correspondent: Katrin Schwenkglenks; MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437
• Product Code: DTN
• CFR Regulation Number: 870.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-30
• Decision Date: 2014-07-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04037691780542	K141432	000
04037691780139	K141432	000
04037691775388	K141432	000
04037691773414	K141432	000
04037691665733	K141432	000
04037691665726	K141432	000
04037691576350	K141432	000
04037691572758	K141432	000