510(k) K043272

PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP by Kendall — Product Code MSD

K043272 is an FDA 510(k) premarket notification submitted by Kendall for the device "PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP". The FDA issued a decision of Substantially Equivalent on December 22, 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
December 22, 2004
Date Received
November 26, 2004
Clearance Type
Special
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