The following data is part of a premarket notification filed by Covidien with the FDA for Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen.
| Device ID | K132567 |
| 510k Number | K132567 |
| Device Name: | ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Dolly Mistry |
| Correspondent | Dolly Mistry COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-15 |
| Decision Date | 2013-11-05 |
| Summary: | summary |