The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Envoy & Vista Brite Tip Guiding Catheters.
| Device ID | K962362 |
| 510k Number | K962362 |
| Device Name: | CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Katherine Trevisol |
| Correspondent | Katherine Trevisol CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-19 |
| Decision Date | 1996-08-08 |
| Summary: | summary |