MULTIPURPOSE DRAINAGE CATHETER


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K111315
Device Name MULTIPURPOSE DRAINAGE CATHETER
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Applicant Contact wanda carpinella
Correspondent
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Correspodent Contact wanda carpinella
Regulation Number 876.5010
Classification Product Code
FGE  
Subsequent Product Codes
GBO   GBX   LJE  
Date Received 05/10/2011
Decision Date 06/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No