510(k) K912540

CONTOUR-PORT by Ideal Medical, Inc. — Product Code LJT

K912540 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "CONTOUR-PORT". The FDA issued a decision of Substantially Equivalent (kit) on August 23, 1991. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
August 23, 1991
Date Received
June 10, 1991
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