ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K112452
Device Name ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
Applicant
ANGIODYNAMICS, INC.
14 plaza drive
latham, 
NY 
12110

Applicant Contact teri juckett
Correspondent
ANGIODYNAMICS, INC.
14 plaza drive
latham, 
NY 
12110

Correspodent Contact teri juckett
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 08/25/2011
Decision Date 03/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No