510(k) K042672

14F DUAL FLOATING DIALYSIS CATHETER/TRAY by Cardio Med Supplies, Inc. — Product Code MSD

K042672 is an FDA 510(k) premarket notification submitted by Cardio Med Supplies, Inc. for the device "14F DUAL FLOATING DIALYSIS CATHETER/TRAY". The FDA issued a decision of Substantially Equivalent on March 23, 2005. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Cardio Med Supplies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2005
Date Received
September 29, 2004
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