The following data is part of a premarket notification filed by Kendall with the FDA for Kendall Argyle 2 Fr Double Lumen Neonatal/pediatric Picc, Model 43304.
| Device ID | K042461 |
| 510k Number | K042461 |
| Device Name: | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Paul W Evans |
| Correspondent | Paul W Evans KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-10 |
| Decision Date | 2004-12-10 |
| Summary: | summary |