510(k) K771426

PEDIATRIC INFUSION T by Quinton, Inc. — Product Code FKB

K771426 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "PEDIATRIC INFUSION T". The FDA issued a decision of Substantially Equivalent on December 20, 1977. The device falls under product code FKB (Connector, Blood Tubing, Infusion T), a Class II device regulated under 21 CFR 876.5820. Quinton, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1977
Date Received
August 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Blood Tubing, Infusion T
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type