MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

MEDTRONIC BIO-MEDICUS, INC.

The following data is part of a premarket notification filed by Medtronic Bio-medicus, Inc. with the FDA for Medtronic Bio-medicus Cannula Insertion Kit.

Pre-market Notification Details

• Device ID: K924643
• 510k Number: K924643
• Device Name: MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344
• Contact: Thomas K Johnsen
• Correspondent: Thomas K Johnsen; MEDTRONIC BIO-MEDICUS, INC. 9600 WEST 76TH ST. Eden Prairie, MN 55344
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-09-14
• Decision Date: 1992-12-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994756767	K924643	000