ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT


Device Classification Name

catheter,intravascular,therapeutic,long-term greater than 30 days

510(k) Number K072196
Device Name ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
Applicant
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Applicant Contact teri juckett
Correspondent
ANGIODYNAMICS, INC.
603 queensbury ave.
queensbury, 
NY 
12804

Correspodent Contact teri juckett
Regulation Number 880.5970
Classification Product Code
LJS  
Date Received 08/07/2007
Decision Date 08/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No