TRAGET DETACHABLE COIL


Device Classification Name

device, neurovascular embolization

510(k) Number K112385
Device Name TRAGET DETACHABLE COIL
Applicant
STRYKER NEUROVASCULAR
47900 bayside parkway
fremont, 
CA 
94538

Applicant Contact james leathley
Correspondent
STRYKER NEUROVASCULAR
47900 bayside parkway
fremont, 
CA 
94538

Correspodent Contact james leathley
Regulation Number 882.5950
Classification Product Code
HCG  
Date Received 08/18/2011
Decision Date 09/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No