The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis 5.2 French Super Torque Plus Cardio Cath.
| Device ID | K914007 |
| 510k Number | K914007 |
| Device Name: | CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Ralph Jugo |
| Correspondent | Ralph Jugo CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-09 |
| Decision Date | 1991-10-18 |