The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Essence Guidewire.
| Device ID | K955637 |
| 510k Number | K955637 |
| Device Name: | ESSENCE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Marlene Valenti |
| Correspondent | Marlene Valenti CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-11 |
| Decision Date | 1996-03-11 |
| Summary: | summary |