510(k) K033676

PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER by Kendall — Product Code MSD

K033676 is an FDA 510(k) premarket notification submitted by Kendall for the device "PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Kendall has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
November 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Implanted
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type