K850861 is an FDA 510(k) clearance for the ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE. This device is classified as a Injector And Syringe, Angiographic (Class II - Special Controls, product code DXT).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on February 18, 1986, 354 days after receiving the submission on March 1, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K850861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1985 |
| Decision Date | February 18, 1986 |
| Days to Decision | 354 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXT — Injector And Syringe, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |