The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Trapease Permanent Vena Filter And Introduction Kit, Models 466-p306a And 466-p306b.
| Device ID | K003964 |
| 510k Number | K003964 |
| Device Name: | TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-22 |
| Decision Date | 2001-01-19 |