K131555 is an FDA 510(k) clearance for the MEDSOURCE IV SAFETY CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Medsource International, LLC (Mound, US). The FDA issued a Cleared decision on January 31, 2014, 247 days after receiving the submission on May 29, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K131555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2013 |
| Decision Date | January 31, 2014 |
| Days to Decision | 247 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 |