K991783 is an FDA 510(k) clearance for the AB-180 XC SYSTEM, MODEL AB-180XC. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II - Special Controls, product code KFM).
Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on November 1, 2000, 526 days after receiving the submission on May 25, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4360.
| 510(k) Number | K991783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1999 |
| Decision Date | November 01, 2000 |
| Days to Decision | 526 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4360 |