The following data is part of a premarket notification filed by Cordis Corp. with the FDA for S.m.a.r.t Nitinol Stent Endosopic Billary System (various).
| Device ID | K003365 |
| 510k Number | K003365 |
| Device Name: | S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Sam Mirza |
| Correspondent | Sam Mirza CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-27 |
| Decision Date | 2000-11-22 |