510(k) K801967

MEDCOMP FEMORAL VEIN CATHETER by Medical Components, Inc. — Product Code FIF

K801967 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. for the device "MEDCOMP FEMORAL VEIN CATHETER". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump), a Class II device regulated under 21 CFR 876.5820. Medical Components, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Dialysis, Single Needle With Uni-Directional Pump
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type