K021475 is an FDA 510(k) clearance for the BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on July 19, 2002, 72 days after receiving the submission on May 8, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K021475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2002 |
| Decision Date | July 19, 2002 |
| Days to Decision | 72 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 |