510(k) K010767

LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES by Horizon Medical Products, Inc. — Product Code LJT

K010767 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "LIFEPORT VTX ACCESS SYSTEM,MODEL VTX 7000 SERIES". The FDA issued a decision of Substantially Equivalent on Apr 10, 2001. 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
Apr 10, 2001
Date Received
Mar 14, 2001
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 K010767. Report a data issue: hello@regdatalab.com.