MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

MEDTRONIC BLOOD SYSTEMS, INC.

The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Modified Intersept Pediatric Blood Filter.

Pre-market Notification Details

• Device ID: K880671
• 510k Number: K880671
• Device Name: MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER
• Classification: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
• Applicant: MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807
• Contact: Sharon D Rockwell
• Correspondent: Sharon D Rockwell; MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807
• Product Code: DTM
• CFR Regulation Number: 870.4260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-02-18
• Decision Date: 1988-05-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20673978707352	K880671	000