K090426 is an FDA 510(k) clearance for the VAKU-8 BLOOD COLLECTION NEEDLES. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on June 12, 2009, 113 days after receiving the submission on February 19, 2009.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K090426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2009 |
| Decision Date | June 12, 2009 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |