The following data is part of a premarket notification filed by Abiomed Inc. with the FDA for Oxy-1 System.
| Device ID | K200109 |
| 510k Number | K200109 |
| Device Name: | OXY-1 System |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Abiomed Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
| Contact | Steve Orwig |
| Correspondent | Ken Ryder Abiomed Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
| Product Code | DTZ |
| Subsequent Product Code | DWA |
| Subsequent Product Code | DWF |
| Subsequent Product Code | KFM |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-17 |
| Decision Date | 2020-10-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001797954 | K200109 | 000 |
| 00860001797947 | K200109 | 000 |
| 00860001797930 | K200109 | 000 |
| 00860001797916 | K200109 | 000 |
| 00860001797909 | K200109 | 000 |
| 00860001797961 | K200109 | 000 |
| 10860001797920 | K200109 | 000 |