510(k) K953823

ARTERIAL VENOUS BLOOD TUBING SET by Medisystems Corp. — Product Code FJK

K953823 is an FDA 510(k) premarket notification submitted by Medisystems Corp. for the device "ARTERIAL VENOUS BLOOD TUBING SET". The FDA issued a decision of Substantially Equivalent on September 23, 1996. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Medisystems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1996
Date Received
August 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type