K031279 is an FDA 510(k) clearance for the SURSHIELD SAFETY WINGED BLOOD COLLECTION SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Terumo Medical Products Hangzhou Co., Ltd. (Elkton, US). The FDA issued a Cleared decision on May 30, 2003, 38 days after receiving the submission on April 22, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K031279 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2003 |
| Decision Date | May 30, 2003 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA - Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |