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.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994947790 | K003724 | 000 |
20613994947783 | K003724 | 000 |
20643169766932 | K003724 | 000 |
20643169766918 | K003724 | 000 |