K854984 is an FDA 510(k) clearance for the CUP MONITORING KIT CVPK-14. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on March 31, 1986, 109 days after receiving the submission on December 12, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K854984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1985 |
| Decision Date | March 31, 1986 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |