510(k) K901688

ARTERIAL/VENOUS BLOODLINES by National Medical Care, Medical Products Div., Inc. — Product Code FJK

K901688 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "ARTERIAL/VENOUS BLOODLINES". The FDA issued a decision of Substantially Equivalent on August 2, 1990. 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. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1990
Date Received
April 12, 1990
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