MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE

Oxygenator, Cardiopulmonary Bypass

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Minimax Plus Hollow Fiber Oxygenator (with Or Without Medtronic/carmeda Bioactive Surface.

Pre-market Notification Details

• Device ID: K933586
• 510k Number: K933586
• Device Name: MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE
• 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: 1993-07-26
• Decision Date: 1994-02-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20613994269779	K933586	000
20613994965138	K933586	000
30673978546194	K933586	000