DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K110936
Device Name DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
Applicant
ANGIODYNAMICS, INC.
14 plaza drive
latham, 
NY 
12110

Applicant Contact david a greer
Correspondent
ANGIODYNAMICS, INC.
14 plaza drive
latham, 
NY 
12110

Correspodent Contact david a greer
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 04/04/2011
Decision Date 06/10/2011
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No