510(k) K133335

POWERPORT IMPLANTABLE PORT by C.R. Bard, Inc. — Product Code LJT

K133335 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "POWERPORT IMPLANTABLE PORT". The FDA issued a decision of Substantially Equivalent on February 14, 2014. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2014
Date Received
October 29, 2013
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