510(k) K892440

KENDALL CURITY EXTENSION TUBES by The Kendal Co. — Product Code FPA

K892440 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL CURITY EXTENSION TUBES". The FDA issued a decision of Substantially Equivalent on July 24, 1989. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1989
Date Received
April 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type