The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Optease Permanent Vena Cava Filter, Models 466-f200a, 466-f200b.
| Device ID | K023116 |
| 510k Number | K023116 |
| Device Name: | CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B |
| Classification | Filter, Intravascular, Cardiovascular |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | DTK |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2002-10-18 |
| Summary: | summary |