The following data is part of a premarket notification filed by Plastimed Laboratoire Pharmaceutique with the FDA for Seldiflex Long-term Central Venous Catheter(40cm & 60cm In Length), Models 63244j20 & 63246j20.
| Device ID | K992424 |
| 510k Number | K992424 |
| Device Name: | SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | PLASTIMED LABORATOIRE PHARMACEUTIQUE 95321 SAINT-LUE-LA-FORET Cedex, FR |
| Contact | Jean-daniel Nury |
| Correspondent | Jean-daniel Nury PLASTIMED LABORATOIRE PHARMACEUTIQUE 95321 SAINT-LUE-LA-FORET Cedex, FR |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-21 |
| Decision Date | 2000-12-29 |
| Summary: | summary |