K834438 is an FDA 510(k) clearance for the TEMPERATURE SENSING FOLEY CATHETER. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 47 days after receiving the submission on December 19, 1983.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K834438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 1983 |
| Decision Date | February 04, 1984 |
| Days to Decision | 47 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 |