Health Line CT CVC— 510(k) K192533

Clearance details

Applicant

Health Line International Corporation

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2019-09-16

Decision date

2019-12-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15
• K252137 — BD Insyte IV Catheter2026-04-02

• K261950 — Health Line Tearaway Introducer2026-06-22
• K222170 — Power Acute Triple Lumen Hemodialysis Catheter2023-01-13
• K200426 — Acute Dual Lumen Hemodialysis Catheter2020-12-24
• K200263 — Health Line CT Midline Catheter2020-03-12
• K160448 — ARTLINE2016-07-12

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →