The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Trapease Permanent Vena Cava Filter And Introduction Kit.
Device ID | K000062 |
510k Number | K000062 |
Device Name: | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT |
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 | 2000-01-10 |
Decision Date | 2000-07-07 |