MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352

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 Modofication To Afffinity 38 Micro Arterial Blood Filter With Carmeda Bioactive Surface, Models Cb351/cb352.

Pre-market Notification Details

• Device ID: K000379
• 510k Number: K000379
• Device Name: MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
• 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: 2000-02-07
• Decision Date: 2000-02-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20681490008529	K000379	000