510(k) K925401

IV FLUID TRANSFER PIN by B. Braun of America, Inc. — Product Code LHI

K925401 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "IV FLUID TRANSFER PIN". The FDA issued a decision of Substantially Equivalent on March 3, 1993. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1993
Date Received
October 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type