510(k) K002901

KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER by The Kendall Company — Product Code MSD

K002901 is an FDA 510(k) premarket notification submitted by The Kendall Company for the device "KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER". The FDA issued a decision of Substantially Equivalent on March 28, 2001. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. The Kendall Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2001
Date Received
September 18, 2000
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