K770868 is an FDA 510(k) clearance for the CATHETER, POLYURETHANE, W/STYLET. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 27, 1977, 46 days after receiving the submission on May 12, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K770868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1977 |
| Decision Date | June 27, 1977 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |