K140136 is an FDA 510(k) clearance for the NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE. 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 February 14, 2014, 28 days after receiving the submission on January 17, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K140136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2014 |
| Decision Date | February 14, 2014 |
| Days to Decision | 28 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 |