510(k) K945752

CELSITE(TM) BRACHIAL VENOUS PORT by B. Braun of America, Inc. — Product Code LJT

K945752 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "CELSITE(TM) BRACHIAL VENOUS PORT". The FDA issued a decision of Substantially Equivalent on May 31, 1995. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1995
Date Received
November 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type