The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Trufill Dcs Orbit Detachable Coil System.
| Device ID | K093973 |
| 510k Number | K093973 |
| Device Name: | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM |
| Classification | Device, Neurovascular Embolization |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Amarilys Machado |
| Correspondent | Amarilys Machado Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-05-26 |
| Summary: | summary |