AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811

Oxygenator, Cardiopulmonary Bypass

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Fusion Oxygenator With Integrated Arterial Filter And Balance Biosurface Model Bb811.

Pre-market Notification Details

• Device ID: K122827
• 510k Number: K122827
• Device Name: AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428
• Contact: Mary E Donlin
• Correspondent: Mary E Donlin; MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-14
• Decision Date: 2012-12-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169178168	K122827	000