The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Kendall with the FDA for Modified Argyle Polyurethane Umbilical Vessel Catheter 2.5fr, 3.5fr, 5 Fr..
| Device ID | K130725 |
| 510k Number | K130725 |
| Device Name: | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. |
| Classification | Catheter, Umbilical Artery |
| Applicant | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Dolly Mistry |
| Correspondent | Dolly Mistry COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-04-17 |
| Summary: | summary |