AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Affinity 20 Micron Arterial Blood Filter With Carmeda Bioactive Surface, Models Cb353/cb354.

Pre-market Notification Details

• Device ID: K001138
• 510k Number: K001138
• Device Name: AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
• Classification: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
• Applicant: MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807
• Contact: Marie Holm
• Correspondent: Marie Holm; MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807
• Product Code: DTM
• CFR Regulation Number: 870.4260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-10
• Decision Date: 2000-04-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20681490008536	K001138	000