PRIMEWIRE PRESTIGE PLUS


Device Classification Name

wire, guide, catheter

510(k) Number K111395
Device Name PRIMEWIRE PRESTIGE PLUS
Applicant
VOLCANO CORPORATION
3661 valley center dr
suite 200
san diego, 
CA 
92130

Applicant Contact marilyn pourazar
Correspondent
VOLCANO CORPORATION
3661 valley center dr
suite 200
san diego, 
CA 
92130

Correspodent Contact marilyn pourazar
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 05/19/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No