INTERSEPT FILTERED CARDIOTOMY RESERVOIR

Oxygenator, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Intersept Filtered Cardiotomy Reservoir.

Pre-market Notification Details

• Device ID: K926226
• 510k Number: K926226
• Device Name: INTERSEPT FILTERED CARDIOTOMY RESERVOIR
• Classification: Oxygenator, Cardiopulmonary Bypass
• Applicant: MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807
• Contact: Norma L Lowe
• Correspondent: Norma L Lowe; MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807
• Product Code: DTZ
• CFR Regulation Number: 870.4350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-12-10
• Decision Date: 1993-06-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994529088	K926226	000
20643169767618	K926226	000
20673978562777	K926226	000
20673978537188	K926226	000