510(k) K033473

MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT by Horizon Medical Products, Inc. — Product Code LJT

K033473 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT". The FDA issued a decision of Substantially Equivalent on Nov 18, 2003. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Horizon Medical Products, Inc. has 15 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 18, 2003
Date Received
Nov 3, 2003
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
510(k)

Source: FDA 510(k) database entry for K033473. Report a data issue: hello@regdatalab.com.