510(k) K870188

NORFOLK MEDICAL BUTTERFLY INFUSION SET by Norfolk Medical Products, Inc. — Product Code FPA

K870188 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "NORFOLK MEDICAL BUTTERFLY INFUSION SET". The FDA issued a decision of Substantially Equivalent on February 10, 1987. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Norfolk Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1987
Date Received
January 16, 1987
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