SELECTRA CS LEAD INTRODUCER SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K110461
Device Name SELECTRA CS LEAD INTRODUCER SYSTEM
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  
Date Received 02/17/2011
Decision Date 04/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No