K132153 is an FDA 510(k) clearance for the SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on December 5, 2013, 146 days after receiving the submission on July 12, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K132153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2013 |
| Decision Date | December 05, 2013 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |