GELBFISH FLEX VASCULAR DILATOR


Device Classification Name

dilator, vessel, for percutaneous catheterization

510(k) Number K030260
Device Name GELBFISH FLEX VASCULAR DILATOR
Original Applicant
VASCUMETRIX, LLC
1058 n. higley rd. #204
mesa, 
AZ 
85205

Original Contact nick raible
Regulation Number 870.1310
Classification Product Code
DRE  
Date Received 01/24/2003
Decision Date 02/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No