The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Brite Tip Catheter Sheath Introducer System.
| Device ID | K971608 |
| 510k Number | K971608 |
| Device Name: | CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-07-21 |
| Summary: | summary |