The following data is part of a premarket notification filed by Abbott with the FDA for Centrimag Pre-connected Pack.
| Device ID | K222297 |
| 510k Number | K222297 |
| Device Name: | CentriMag Pre-connected Pack |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Abbott 6035 Stoneridge Drive Pleasanton, CA 94588 |
| Contact | Kim Bondarenko |
| Correspondent | Kim Bondarenko Abbott 6035 Stoneridge Drive Pleasanton, CA 94588 |
| Product Code | DTZ |
| Subsequent Product Code | DTQ |
| Subsequent Product Code | DTR |
| Subsequent Product Code | DWA |
| Subsequent Product Code | DWF |
| Subsequent Product Code | KFM |
| Subsequent Product Code | KRI |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-01 |
| Decision Date | 2022-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067036414 | K222297 | 000 |