The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Palmaz Xl Tanshepatic Biliary Stents.
| Device ID | K993091 |
| 510k Number | K993091 |
| Device Name: | PALMAZ XL TANSHEPATIC BILIARY STENTS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Ariel Mactavish |
| Correspondent | Ariel Mactavish CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032057377 | K993091 | 000 |
| 20705032057353 | K993091 | 000 |
| 20705032057322 | K993091 | 000 |
| 10705032057325 | K993091 | 000 |