K010197 is an FDA 510(k) clearance for the EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on May 14, 2001, 112 days after receiving the submission on January 22, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K010197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2001 |
| Decision Date | May 14, 2001 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |