K934591 is an FDA 510(k) clearance for the CLAVE VIAL ACCESS SPIKE. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Icu Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 16, 1994, 145 days after receiving the submission on September 24, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K934591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1993 |
| Decision Date | February 16, 1994 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMI — Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |