ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT


Device Classification Name

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

510(k) Number K030415
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 02/07/2003
Decision Date 04/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls