QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000

Oxygenator, Cardiopulmonary Bypass

MAQUET CARDIOPULMONARY AG

The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Adult With And Without Integrated Arterial Filter With Softline Coating, Model# Hmo 70000, Hmo 71000.

Pre-market Notification Details

• Device ID: K082117
• 510k Number: K082117
• Device Name: QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145
• Contact: Katrin Schwenkglenks
• Correspondent: Katrin Schwenkglenks; MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-07-28
• Decision Date: 2009-02-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04037691508009	K082117	000