MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K103353
Device Name MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY 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  
Date Received 11/16/2010
Decision Date 01/14/2011
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