K770404 is an FDA 510(k) clearance for the OBTURATOR. This device is classified as a Stylet, Catheter (Class II - Special Controls, product code DRB).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 16, 1977, 13 days after receiving the submission on March 3, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1380.
| 510(k) Number | K770404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1977 |
| Decision Date | March 16, 1977 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRB — Stylet, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1380 |