K861586 is an FDA 510(k) clearance for the LOPEZ VALVE. This device is classified as a Check Valve, Retrograde Flow (in-line) (Class II - Special Controls, product code MJF).
Submitted by Icu Medical, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on August 18, 1986, 111 days after receiving the submission on April 29, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K861586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1986 |
| Decision Date | August 18, 1986 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | MJF — Check Valve, Retrograde Flow (in-line) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |