AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE

Reservoir, Blood, Cardiopulmonary Bypass

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Fusion Cardiotomy/venous Reservoir With Balance Biosurface.

Pre-market Notification Details

• Device ID: K132972
• 510k Number: K132972
• Device Name: AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
• Classification: Reservoir, Blood, Cardiopulmonary Bypass
• Applicant: MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428
• Contact: Julia A Nelson
• Correspondent: Julia A Nelson; MEDTRONIC, INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428
• Product Code: DTN
• CFR Regulation Number: 870.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-23
• Decision Date: 2013-10-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169354876	K132972	000
00643169354869	K132972	000