The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Trapease Permanent Vena Cava Filter With The Visease Angiographic Vessel Dilator; Models 466-p306au & 466-p306bu.
| Device ID | K020316 |
| 510k Number | K020316 |
| Device Name: | CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-30 |
| Decision Date | 2002-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032009475 | K020316 | 000 |
| 20705032009451 | K020316 | 000 |