AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE

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 Af100 Arterial Filter With Carmeda Bioactive Surface.

Pre-market Notification Details

• Device ID: K123351
• 510k Number: K123351
• Device Name: AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
• Classification: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
• Applicant: MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432
• Contact: Julia A Nelson
• Correspondent: Julia A Nelson; MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432
• Product Code: DTM
• CFR Regulation Number: 870.4260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2012-10-31
• Decision Date: 2013-03-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20643169878116	K123351	000
20643169178032	K123351	000