VALET MICRO CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K112035
Device Name VALET MICRO CATHETER
Applicant
VOLCANO CORPORATION
1 fortune drive
billerica, 
MA 
01821

Applicant Contact lisa quaglia
Correspondent
VOLCANO CORPORATION
1 fortune drive
billerica, 
MA 
01821

Correspodent Contact lisa quaglia
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 07/15/2011
Decision Date 01/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No