The following data is part of a premarket notification filed by Cordis Corp. with the FDA for 5 Fr And 6 Fr Infiniti Angiographic Catheter.
| Device ID | K970854 |
| 510k Number | K970854 |
| Device Name: | 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-09-30 |
| Summary: | summary |