The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Smart Nitinol Self-expanding Stent, Model C06120mb, C07120mb, C08120mb, C06150mb, C07150mb, C08150mb.
| Device ID | K062798 |
| 510k Number | K062798 |
| Device Name: | SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 7 POWDER HORN DRIVE Warren, NJ 07059 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk CORDIS CORP. 7 POWDER HORN DRIVE Warren, NJ 07059 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-19 |
| Decision Date | 2008-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032024270 | K062798 | 000 |