SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75


Device Classification Name

catheter, percutaneous

510(k) Number K111154
Device Name SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, 
OR 
97035

Applicant Contact jon brumbaugh
Correspondent
BIOTRONIK, INC.
6024 jean road
lake oswego, 
OR 
97035

Correspodent Contact jon brumbaugh
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
DRE  
Date Received 04/25/2011
Decision Date 05/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No