K791873 is an FDA 510(k) clearance for the USCI SAFE-T-CLOTH THERMODILUTION CAT.. This device is classified as a Probe, Thermodilution (Class II - Special Controls, product code KRB).
Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 53 days after receiving the submission on September 21, 1979.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1915.
| 510(k) Number | K791873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1979 |
| Decision Date | November 13, 1979 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRB — Probe, Thermodilution |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1915 |