K080077 is an FDA 510(k) clearance for the CLAVE STOPCOCK. This device is classified as a Stopcock, I.v. Set (Class II - Special Controls, product code FMG).
Submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 13, 2008, 33 days after receiving the submission on January 11, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K080077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2008 |
| Decision Date | February 13, 2008 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMG — Stopcock, I.v. Set |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |