K770256 is an FDA 510(k) clearance for the CATHETERS, SILICONE COATED. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1977, 7 days after receiving the submission on February 10, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K770256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1977 |
| Decision Date | February 17, 1977 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |