8FR TURBO – TANDEM SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K112032
Device Name 8FR TURBO – TANDEM SYSTEM
Applicant
SPECTRANETICS CORP.
9965 federal dr.
colorado springs, 
CO 
80921

Applicant Contact shelley wilcox
Correspondent
SPECTRANETICS CORP.
9965 federal dr.
colorado springs, 
CO 
80921

Correspodent Contact shelley wilcox
Regulation Number 870.1250
Classification Product Code
DQY  
Subsequent Product Code
MCW  
Date Received 07/15/2011
Decision Date 10/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No