MODIFICATION TO GELBFISH VASCULAR DILATORS


Device Classification Name

dilator, vessel, for percutaneous catheterization

510(k) Number K023507
Device Name MODIFICATION TO GELBFISH VASCULAR DILATORS
Original Applicant
VASCUMETRIX, LLC
2824 north power rd., #113-278
mesa, 
AZ 
85215 -1674

Original Contact nick raible
Regulation Number 870.1310
Classification Product Code
DRE  
Date Received 10/18/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No