510(k) K926139

CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH by Bard Access Systems, Inc. — Product Code LJT

K926139 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH". The FDA issued a decision of Substantially Equivalent on January 3, 1995. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1995
Date Received
December 7, 1992
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