SCOUTPRO CS LEAD INTRODUCER SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K080988
Device Name SCOUTPRO 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  
Subsequent Product Codes
DQX   DRE  
Date Received 04/07/2008
Decision Date 05/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No