MAHURKAR OPLUS CATHETER, MODEL 13.5 FR


Device Classification Name

catheter, hemodialysis, non-implanted

510(k) Number K030209
Device Name MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
Original Applicant
THE KENDALL COMPANY
15 hampshire st.
mansfield, 
MA 
02048

Original Contact regina yeh
Regulation Number 876.5540
Classification Product Code
MPB  
Date Received 01/21/2003
Decision Date 05/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls