SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED


Device Classification Name

catheter, percutaneous

510(k) Number K072329
Device Name SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
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 08/20/2007
Decision Date 03/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No