The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To Cordis Palmaz Corinthian Iq Transhepatic Biliary Stent, Models Pq294b, Pq394b.
| Device ID | K994156 |
| 510k Number | K994156 |
| Device Name: | MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Charles J Ryan |
| Correspondent | Charles J Ryan CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 2000-01-07 |
| Summary: | summary |