The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for 5f Envoy Guiding Catheter (modification).
| Device ID | K954251 |
| 510k Number | K954251 |
| Device Name: | 5F ENVOY GUIDING CATHETER (MODIFICATION) |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marlene Wright Valenti |
| Correspondent | Marlene Wright Valenti CORDIS NEUROVASCULAR, INC. 14740 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 | 1995-08-24 |
| Decision Date | 1995-10-23 |