510(k) K943770

LOW VOLUME MULTIPORT by B. Braun of America, Inc. — Product Code FPA

K943770 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "LOW VOLUME MULTIPORT". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code FPA (Set, Administration, Intravascular), 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
April 10, 1995
Date Received
August 2, 1994
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