K780567 is an FDA 510(k) clearance for the AORTIC PUMP. This device is classified as a Instruments, Surgical, Cardiovascular (Class I - General Controls, product code DWS).
Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978, 22 days after receiving the submission on April 6, 1978.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4500.
| 510(k) Number | K780567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1978 |
| Decision Date | April 28, 1978 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWS — Instruments, Surgical, Cardiovascular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4500 |