510(k) K994196

HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM by Horizon Medical Products, Inc. — Product Code LJT

K994196 is an FDA 510(k) premarket notification submitted by Horizon Medical Products, Inc. for the device "HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM". The FDA issued a decision of Substantially Equivalent on Feb 10, 2000. 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
Feb 10, 2000
Date Received
Dec 13, 1999
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
510(k)

Source: FDA 510(k) database entry for K994196. Report a data issue: hello@regdatalab.com.