K161779 is an FDA 510(k) clearance for the MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV 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 (Chaska, US). The FDA issued a Cleared decision on November 3, 2016, 127 days after receiving the submission on June 29, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K161779 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2016 |
| Decision Date | November 03, 2016 |
| Days to Decision | 127 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 |