The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Palmaz Genesis Transhepatic Biliary Stent.
| Device ID | K012087 |
| 510k Number | K012087 |
| Device Name: | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Chuck Ryan |
| Correspondent | Chuck Ryan 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 | 2001-07-03 |
| Decision Date | 2001-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032057629 | K012087 | 000 |
| 20705032057445 | K012087 | 000 |
| 20705032057537 | K012087 | 000 |
| 20705032057575 | K012087 | 000 |
| 20705032057612 | K012087 | 000 |
| 20705032057391 | K012087 | 000 |
| 20705032057414 | K012087 | 000 |
| 20705032057438 | K012087 | 000 |
| 20705032057452 | K012087 | 000 |
| 20705032057476 | K012087 | 000 |
| 20705032057490 | K012087 | 000 |
| 20705032057506 | K012087 | 000 |
| 20705032057520 | K012087 | 000 |
| 20705032057544 | K012087 | 000 |
| 20705032057568 | K012087 | 000 |
| 20705032057582 | K012087 | 000 |
| 20705032057605 | K012087 | 000 |
| 20705032057407 | K012087 | 000 |