Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010882065

FEI Number

3006097687

Entity Name

HEALTH LINE INTERNATIONAL CORPORATION

City/State/Country

Salt Lake City, UT, US

Establishment Address

260 North Ace Yeager Court, Unit D, Salt Lake City, UT 84116, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HEALTH LINE INTERNATIONAL CORPORATION (Owner Number: 9096670)

Owner / Operator Contact Address

260 North Ace Yeager Court, Unit D, Salt Lake City, UT 84116, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123065

PMA Number

N/A

All Registered Proprietary Names

Cascade Synergy PICC Dark Blue DulaCap IV Pole Strip Uni-Cap IV Administration Set with Check Valve DulaCap IV Pole Strip PIV Suture Wing Dark Blue DualCap Artline Health Line CT CVC Health Line CT Midline Catheter Light Blue DualCap Solo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-10-13
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2010-09-14
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2017-03-01
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2015-06-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-05
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2017-03-01
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-02-07
KGS	Retention Device, Suture	General, Plastic Surgery	Class 1	878.4930	2017-09-22
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2013-05-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-08-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-08-04
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-10-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-10-06
QBP	Cap, Device Disinfectant	General Hospital	Class 2	880.5440	2013-05-01

Official Correspondent

Daniel Caycho

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HEALTH LINE INTERNATIONAL CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171618	Medcomp (Dba Medical Components, Inc.)	Symetrex Long Term Hemodialysis Catheter	2017-11-16
K111817	Covidien	PALINDROME RT CHRONIC CATHETER	2011-08-30
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.
Z-0027-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010882065. Last updated year: 2026. Please use registration number 3010882065 when referencing this establishment in official correspondence.