DIRECTVISION CATHETER, UNCOATED


Device Classification Name

catheter, retention type, balloon

510(k) Number K110214
Device Name DIRECTVISION CATHETER, UNCOATED
Applicant
PERCUVISION
200 homer ave, 2nd floor
ashland, 
MA 
01721

Applicant Contact fides maldonado
Correspondent
PERCUVISION
200 homer ave, 2nd floor
ashland, 
MA 
01721

Correspodent Contact fides maldonado
Regulation Number 876.5130
Classification Product Code
EZL  
Date Received 01/25/2011
Decision Date 05/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No