Submission Details
| 510(k) Number | K020189 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
EXEL BUTTERFLY SCALP VEIN SET
Mar 2003
Decision
433d
Days
Class 2
Risk
About This 510(k) Submission
K020189 is an FDA 510(k) clearance for the EXEL BUTTERFLY SCALP VEIN SET, 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 review panel. Regulated under 21 CFR 880.5440.
Device Classification
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
Manufacturer
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