The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Trapease Permanent Vena Cava Filter And Introduction Kit, Model 466-p306a.
| Device ID | K010083 |
| 510k Number | K010083 |
| Device Name: | TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A |
| 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 | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-11 |
| Decision Date | 2001-06-06 |