K870977 is an FDA 510(k) clearance for the PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on April 1, 1987, 22 days after receiving the submission on March 10, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K870977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1987 |
| Decision Date | April 01, 1987 |
| Days to Decision | 22 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 |