K113429 is an FDA 510(k) clearance for the SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH 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 March 12, 2012, 112 days after receiving the submission on November 21, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K113429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2011 |
| Decision Date | March 12, 2012 |
| Days to Decision | 112 days |
| Submission Type | Special |
| 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 |