The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Trufill Dcs Orbit Detachable Coil And Trufill Dcs Syringe, Also Known As Trufill Dcs Orbit Detachable Coil System.
| Device ID | K032553 |
| 510k Number | K032553 |
| Device Name: | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Contact | Amarilys Machado |
| Correspondent | Amarilys Machado CORDIS NEUROVASCULAR, INC. 14000 N.W. 57TH CT. Miami Lakes, FL 33014 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-19 |
| Decision Date | 2003-09-23 |