510(k) K970442

TARGET VITAL-PORT VASCULAR ACCESS SYSTEM by Med Institute, Inc. — Product Code LJT

K970442 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "TARGET VITAL-PORT VASCULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 30, 1997. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Med Institute, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1997
Date Received
February 5, 1997
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