K934561 is an FDA 510(k) clearance for the ONE TIME VIAL ACCESS SPIKE. This device is classified as a Syringe, Piston (Class II - Special Controls, product code FMF).
Submitted by Icu Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on February 10, 1994, 142 days after receiving the submission on September 21, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K934561 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 21, 1993 |
| Decision Date | February 10, 1994 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMF — Syringe, Piston |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |