SELECTRA ACCESSORY KIT


Device Classification Name

catheter, percutaneous

510(k) Number K111839
Device Name SELECTRA ACCESSORY KIT
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
DQX  
Date Received 06/29/2011
Decision Date 09/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No