CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B

Heat-exchanger, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Cbmyotherm Xp Cardioplegia Delivery System With Carmeda Bioactive Surface, Models Cb41 And Cb41-b.

Pre-market Notification Details

• Device ID: K003724
• 510k Number: K003724
• Device Name: CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
• Classification: Heat-exchanger, Cardiopulmonary Bypass
• Applicant: MEDTRONIC VASCULAR 7600 NORTHLAND DR. Minneapolis, MN 55428
• Contact: Marie Holm
• Correspondent: Marie Holm; MEDTRONIC VASCULAR 7600 NORTHLAND DR. Minneapolis, MN 55428
• Product Code: DTR
• CFR Regulation Number: 870.4240 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-12-04
• Decision Date: 2000-12-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994947790	K003724	000
20613994947783	K003724	000
20643169766932	K003724	000
20643169766918	K003724	000