510(k) K993024

CELSITE IMPLANTABLE PORT WITH VALVED CATHETER by B. Braun of America, Inc. — Product Code LJT

K993024 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "CELSITE IMPLANTABLE PORT WITH VALVED CATHETER". The FDA issued a decision of Substantially Equivalent on March 13, 2000. 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
March 13, 2000
Date Received
September 9, 1999
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