510(k) K982507

MINI POLYURETHANE CATHETER by Med Institute, Inc. — Product Code LJT

K982507 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "MINI POLYURETHANE CATHETER". The FDA issued a decision of Substantially Equivalent on September 16, 1998. 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 16, 1998
Date Received
July 20, 1998
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