K130725 is an FDA 510(k) clearance for the MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.. This device is classified as a Catheter, Umbilical Artery (Class II - Special Controls, product code FOS).
Submitted by Covidien Lp, Formerly Registered AS Kendall (Mansfield, US). The FDA issued a Cleared decision on April 17, 2013, 30 days after receiving the submission on March 18, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K130725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2013 |
| Decision Date | April 17, 2013 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOS — Catheter, Umbilical Artery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |