TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT


Device Classification Name

device, neurovascular embolization

510(k) 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
Applicant
CORDIS NEUROVASCULAR, INC.
14201 nw 60th avenue
miami lakes, 
FL 
33014

Applicant Contact amarilys machado
Correspondent
CORDIS NEUROVASCULAR, INC.
14201 nw 60th avenue
miami lakes, 
FL 
33014

Correspodent Contact amarilys machado
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 04/04/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No