PALINDROME RT CHRONIC CATHETER


Device Classification Name

catheter, hemodialysis, implanted

510(k) Number K111817
Device Name PALINDROME RT CHRONIC CATHETER
Applicant
COVIDIEN
15 hampshire street
mansfield, 
MA 
02048

Applicant Contact wing ng
Correspondent
COVIDIEN
15 hampshire street
mansfield, 
MA 
02048

Correspodent Contact wing ng
Regulation Number 876.5540
Classification Product Code
MSD  
Date Received 06/27/2011
Decision Date 08/30/2011
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No