510(k) K942103

L-CATH CATHETER SYSTEM - PORT L-CATH by Luther Medical Products, Inc. — Product Code LJT

K942103 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "L-CATH CATHETER SYSTEM - PORT L-CATH". The FDA issued a decision of Substantially Equivalent on July 26, 1994. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Luther Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1994
Date Received
May 2, 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