The following data is part of a premarket notification filed by Cardiac Assist, Inc. with the FDA for Ab-180 Xc System, Model Ab-180xc.
| Device ID | K991783 |
| 510k Number | K991783 |
| Device Name: | AB-180 XC SYSTEM, MODEL AB-180XC |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Contact | Richard G Confer |
| Correspondent | Richard G Confer CARDIAC ASSIST, INC. 240 ALPHA DR. Pittsburgh, PA 15238 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 2000-11-01 |
| Summary: | summary |