K162601 is an FDA 510(k) clearance for the Infusion Set for Single Use. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Shinva Ande Healthcare Apparatus Co., Ltd. (Zibo, CN). The FDA issued a Cleared decision on May 31, 2017, 254 days after receiving the submission on September 19, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K162601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2016 |
| Decision Date | May 31, 2017 |
| Days to Decision | 254 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 |