Data / Medical devices / United States / Health Line International Corporation
Health Line International Corporation: FDA-registered device maker in Salt Lake City, UT, United States, 13 510(k) clearances
Health Line International Corporation is registered with the FDA (registration 3010882065) in Salt Lake City, UT, United States. It lists 12 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 13, 2023. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010882065
- FEI number
- 3006097687
- Address
- 260 North Ace Yeager Court Unit D, Salt Lake City, UT, United States, 84116
- Owner or operator
- HEALTH LINE INTERNATIONAL CORPORATION (9096670)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- January 16, 2007
- Registered through
- 2026
- Brand names listed
- Acute Dual Lumen Hemodialysis Catheter, Acute Triple Lumen Hemodialysis Catheter, Artline, Cascade, Dark Blue DualCap, Dark Blue DulaCap IV Pole Strip, DulaCap IV Pole Strip, Health Line CT CVC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Specification developer | accessdata.fda.gov |
| Cap, Device Disinfectant | QBP | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Hemodialysis, Implanted | MSD | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Hemodialysis, Non-Implanted | MPB | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Manufacturer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 13, 2023 | K222170 | Power Acute Triple Lumen Hemodialysis Catheter | NIE | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| December 24, 2020 | K200426 | Acute Dual Lumen Hemodialysis Catheter | MPB | Unknown | Health Line International Corporation | accessdata.fda.gov |
| March 12, 2020 | K200263 | Health Line CT Midline Catheter | FOZ | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| December 10, 2019 | K192533 | Health Line CT CVC | FOZ | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| July 12, 2016 | K160448 | ARTLINE | DQY | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| May 22, 2015 | K142806 | DualCap | QBP | Substantially Equivalent | Catheter Connections, Inc. | accessdata.fda.gov |
| November 19, 2014 | K142399 | DualCap IV Pole Strips(Disinfectant Caps for Male Luers) | QBP | Substantially Equivalent | Catheter Connections, Inc. | accessdata.fda.gov |
| January 9, 2014 | K130851 | CASCADE HEMODIALYSIS/APHERESIS CATHETER | MSD | Unknown | Health Line International Corporation | accessdata.fda.gov |
| January 22, 2013 | K123967 | CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS | QBP | Substantially Equivalent | Catheter Connections, Inc. | accessdata.fda.gov |
| December 14, 2012 | K123065 | CATHETER CONNECTIONS DUALCAP SOLO | QBP | Substantially Equivalent | Catheter Connections, Inc. | accessdata.fda.gov |
| August 19, 2010 | K101329 | SYNERGY CT PICC | LJS | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| August 31, 2007 | K070630 | HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE | FPA | Substantially Equivalent | Health Line International Corporation (Hlic) | accessdata.fda.gov |
| May 31, 2006 | K060352 | HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS | FPA | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Hemodialysis, Implanted
- All makers of Accessories, Catheter
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Set, Administration, Intravascular
- All makers of Catheter, Hemodialysis, Non-Implanted
- All makers of Catheter, Percutaneous
Updated January 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.