K061483 is an FDA 510(k) clearance for the VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Greiner Bio-One North America, Inc. (Baldwin, US). The FDA issued a Cleared decision on August 14, 2006, 76 days after receiving the submission on May 30, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K061483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2006 |
| Decision Date | August 14, 2006 |
| Days to Decision | 76 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 |