K020189 is an FDA 510(k) clearance for the EXEL BUTTERFLY 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 March 27, 2003, 433 days after receiving the submission on January 18, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K020189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2002 |
| Decision Date | March 27, 2003 |
| Days to Decision | 433 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 |