The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Perflex Stainless Steel Stent And Delivery System.
| Device ID | K980653 |
| 510k Number | K980653 |
| Device Name: | PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 35 & 40 TECHNOLOGY DR. Warren, NJ 07059 |
| Contact | Charles J Ryan |
| Correspondent | Charles J Ryan CORDIS CORP. 35 & 40 TECHNOLOGY DR. Warren, NJ 07059 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-11 |
| Decision Date | 1998-06-09 |
| Summary: | summary |