RADIONICS XDC EXTERNAL VENTRICULAR CATHETER


Device Classification Name

shunt, central nervous system and components

510(k) Number K992379
Device Name RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
Applicant
RADIONICS, INC.
22 terry ave.
burlington, 
MA 
01803 -2516

Applicant Contact kevin j o’connell
Correspondent
RADIONICS, INC.
22 terry ave.
burlington, 
MA 
01803 -2516

Correspodent Contact kevin j o’connell
Regulation Number 882.5550
Classification Product Code
JXG  
Date Received 07/16/1999
Decision Date 09/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No