The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Affinity Nt Hollow Fiber Oxygenator With Plasma Resistant Fiber With Carmeda Bioactive Surface, Model Cb511.
Device ID | K000430 |
510k Number | K000430 |
Device Name: | AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | MEDTRONIC VASCULAR 4633 EAST LA PALMA AVE. Anaheim, CA 92807 |
Contact | Debra Kridner |
Correspondent | Debra Kridner MEDTRONIC VASCULAR 4633 EAST LA PALMA AVE. Anaheim, CA 92807 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-09 |
Decision Date | 2000-02-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994529101 | K000430 | 000 |
20613994529095 | K000430 | 000 |
00643169767805 | K000430 | 000 |
20681490008574 | K000430 | 000 |
20721902333884 | K000430 | 000 |