510(k) K153359

BardPort®, SlimPort®, and X-Port® Implanted Ports by C.R. Bard, Inc. — Product Code LJT

K153359 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BardPort®, SlimPort®, and X-Port® Implanted Ports". The FDA issued a decision of Substantially Equivalent on May 20, 2016. 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
May 20, 2016
Date Received
November 20, 2015
Clearance Type
Special
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