Medical Device Manufacturer · US , Clearfield , UT

Health Line International Corporation

11 submissions · 9 cleared · Since 2006
11
Total
9
Cleared
0
Denied

Health Line International Corporation — FDA 510(k) Submissions

Health Line International Corporation has submitted 11 FDA 510(k) premarket notifications since 2006, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days, Set, Administration, Intravascular, Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Catheter, Hemodialysis, Non-implanted, Catheter, Hemodialysis, Triple Lumen, Non-implanted . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Power Acute Triple Lumen Hemodialysis Catheter
K222170 · NIE Catheter, Hemodialysis,... · Gastroenterology & Urology
Jan 2023 176d
Acute Dual Lumen Hemodialysis Catheter
K200426 · MPB Catheter, Hemodialysis,... · Gastroenterology & Urology
Dec 2020 307d
Health Line CT Midline Catheter
K200263 · FOZ Catheter, Intravascular,... · General Hospital
Mar 2020 38d
Health Line CT CVC
K192533 · FOZ Catheter, Intravascular,... · General Hospital
Dec 2019 85d
ARTLINE
K160448 · DQY Catheter, Percutaneous · Cardiovascular
Jul 2016 145d
NEXUS MIDLINE CT CATHETER
K140270 · FOZ Catheter, Intravascular,... · General Hospital
Aug 2014 198d
CASCADE HEMODIALYSIS/APHERESIS CATHETER
K130851 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Jan 2014 288d
UNI-PICC
K130034 · LJS Catheter, Intravascular,... · General Hospital
Mar 2013 60d
HLIC NEEDLE-LESS VALVE
K120548 · FPA Set, Administration,... · General Hospital
May 2012 71d
SYNERGY CT PICC
K101329 · LJS Catheter, Intravascular,... · General Hospital
Aug 2010 99d
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
K060352 · FPA Set, Administration,... · General Hospital
May 2006 107d
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