K003627 is an FDA 510(k) clearance for the EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET. This device is classified as a Needle, Hypodermic, Single Lumen (Class II - Special Controls, product code FMI).
Submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on February 8, 2001, 76 days after receiving the submission on November 24, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.
| 510(k) Number | K003627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2000 |
| Decision Date | February 08, 2001 |
| Days to Decision | 76 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 |