Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722746

FEI Number

1000306216

Entity Name

MEDRON, LLC

City/State/Country

SALT LAKE CITY, UT, US

Establishment Address

1518 S Gladiola St, SALT LAKE CITY, UT 84104, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MEDRON, LLC (Owner Number: 9010139)

Owner / Operator Contact Address

1518 SOUTH GLADIOLA ST., --, Salt Lake City, UT 84104, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

0792-002, 12-14F Dilator Silhouette Circuits C-1781-PD SIL II PEDIATRIC CIRCUIT / Silhouette 2 Circuit, Pediatric Silhouette Circuits C-1781-MD SIL II MEDIUM CIRCUIT / Silhouette 2 Circuit, Medium Silhouette Circuits C-1781-LG SIL II LARGE CIRCUIT / Silhouette Circuit, Large Silhouette Circuits C-1781-SM SIL II SMALL CIRCUIT / Silhouette 2 Circuit, Small EDS 3 Gen II with Ventricular Catheter EDS 3 Gen II

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	2014-12-30
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-26
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2013-03-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-12-30
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2020-04-20
LFJ	Catheter, Subclavian	Gastroenterology, Urology	Class 2	876.5540	2013-03-29
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-29
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-12-21
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-12-15
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2013-03-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2013-03-29
FKA	Dilator, Vessel	Gastroenterology, Urology	Class 2	876.5540	2007-12-11
LFK	Catheter, Femoral	Gastroenterology, Urology	Class 2	876.5540	2007-12-11
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-03-29
LKK	Pump, Infusion, Implanted, Programmable	Unknown	Class 3	N/A	2016-12-15
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2018-12-21
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2013-12-29
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2020-04-20
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2024-11-04
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2020-04-20
DQR	Cannula, Catheter	Cardiovascular	Class 2	870.1300	2013-03-29
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2014-12-30
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2013-03-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-03-25
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2013-03-29
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-29
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-03-28
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-29
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2013-03-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-12-15
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2016-12-15
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-03-28
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-26
NFK	Kit, Repair, Catheter, Hemodialysis	Gastroenterology, Urology	Class 2	876.5540	2013-03-26
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-06-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-12-30
DTK	Filter, Intravascular, Cardiovascular	Cardiovascular	Class 2	870.3375	2013-03-25
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2018-12-21
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2013-03-29
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-03-25
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2016-12-15
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2014-12-30
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-06-13
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2013-03-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2013-03-29
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-03-25
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2013-03-25
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-12-21

Official Correspondent

Sommer Altvater

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDRON, LLC

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
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26

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 1722746. Last updated year: 2026. Please use registration number 1722746 when referencing this establishment in official correspondence.