AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Affinity 20 Micron Arterial Blood Filter, Model 353/354.

Pre-market Notification Details

• Device ID: K994208
• 510k Number: K994208
• Device Name: AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
• Classification: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
• Applicant: MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038
• Contact: Marie Holm
• Correspondent: Marie Holm; MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038
• Product Code: DTM
• CFR Regulation Number: 870.4260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-14
• Decision Date: 2000-01-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50613994094341	K994208	000
20643169858842	K994208	000
20643169767748	K994208	000
20681490008024	K994208	000
20885074252227	K994208	000