The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Avanti+catheter Sheath Introducer System.
| Device ID | K970392 |
| 510k Number | K970392 |
| Device Name: | CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Elena S Jugo |
| Correspondent | Elena S Jugo CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-04-24 |
| Summary: | summary |