510(k) K150733

Vital-Port Vascular Access System Power Injectable Port by Cook Incorporated — Product Code LJT

K150733 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Vital-Port Vascular Access System Power Injectable Port". The FDA issued a decision of Substantially Equivalent on May 21, 2015. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Cook Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2015
Date Received
March 20, 2015
Clearance Type
Special
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