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 |