The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Cordis Optease Vena Cava Filter, Models 466-f220a And 466-f220b; Retrievable Catheter, Model 466-c220f.
| Device ID | K034050 |
| 510k Number | K034050 |
| Device Name: | CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | CORDIS CORPORATION 7 POWDER HORN DRIVE Warren, NJ 07059 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall CORDIS CORPORATION 7 POWDER HORN DRIVE Warren, NJ 07059 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-30 |
| Decision Date | 2004-03-22 |
| Summary: | summary |