510(k) K932411

VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA by Med Institute, Inc. — Product Code LJT

K932411 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "VITAL-PORT VASC ACCESS SYS W/DUAL LUM INJECTROL CA". The FDA issued a decision of Substantially Equivalent on September 19, 1994. 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
September 19, 1994
Date Received
May 18, 1993
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