K853275 is an FDA 510(k) clearance for the CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Icu Medical, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on August 16, 1985, 11 days after receiving the submission on August 5, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K853275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1985 |
| Decision Date | August 16, 1985 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |