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 Or Trufill Dcs Syringe Ii, Also Known As The Trufill Dcs Orbit.
| Device ID | K080967 |
| 510k Number | K080967 |
| Device Name: | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT |
| Classification | Device, Neurovascular Embolization |
| Applicant | CORDIS NEUROVASCULAR, INC. 14201 NW 60TH AVENUE Miami Lakes, FL 33014 |
| Contact | Amarilys Machado |
| Correspondent | Amarilys Machado CORDIS NEUROVASCULAR, INC. 14201 NW 60TH AVENUE 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 | 2008-04-04 |
| Decision Date | 2008-05-02 |