VISIONS PV .035 DITITAL IVUS CATHETER


Device Classification Name

catheter, ultrasound, intravascular

510(k) Number K121273
Device Name VISIONS PV .035 DITITAL IVUS CATHETER
Applicant
VOLCANO CORPORATION
3721 valley centre dr ste 500
san diego, 
CA 
92130

Applicant Contact marilyn pourazar
Correspondent
VOLCANO CORPORATION
3721 valley centre dr ste 500
san diego, 
CA 
92130

Correspodent Contact marilyn pourazar
Regulation Number 870.1200
Classification Product Code
OBJ  
Date Received 04/27/2012
Decision Date 09/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No