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 |