Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1043729

FEI Number

1043729

Entity Name

ATRION MEDICAL PRODUCTS, INC.

City/State/Country

ARAB, AL, US

Establishment Address

1426 CURT FRANCIS RD., ARAB, AL 35016, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ATRION CORP. (Owner Number: 9914015)

Owner / Operator Contact Address

ONE ALLENTOWN PKWY., --, Allen, TX 75002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060643

PMA Number

N/A

All Registered Proprietary Names

QL 1015 Inflation Device; QL 1020 Inflation Device QL Inflation Device Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1030; BD Eagle Inflation Device 20cc/30ATM REF 325130 BD Eagle Inflation Device 10cc/30ATM REF 325110 MISTER QL Series Fluid Dispensing Syringes QL Fluid Dispensing Syringe Atrion QL Fluid Dispensing Syringe; Atrion QL4515 Ref 96531 Atrion QL2530 Ref 96529 QL Inflation Device Atrion QL4515 REF 96518 Medtronic QL1430 REF 96473 Atrion QL6020 REF 96522 Atrion QL4515 Ref 96530 Atrion QL Inflation Device; Atrion QL Disposable Inflation Device QL2030 AQL1015 Inflation Device QL 1020 Inflation Device QL Inflation Device LB Medical QL1020 Atrion QL Inflation Device; Atrion QL Disposable Inflation Device; Atrion QL1015, QL1030; NeedleVISE, 5 Port NeedleVISE Sharps Securing System Edwards Inflation Device REF 96402 Edwards Inflation Device REF 96417 QL Series Locking Syringes QL Locking Syringe Edwards Locking Syringe REF 96406 Atrion QL38X Locking Syringe Device REF 96527

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2015-08-18
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2007-11-19
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2003-01-27
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-11-19
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2018-01-09
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2007-11-19
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2007-11-19
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2007-11-19
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2012-12-19
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2013-01-24
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2007-11-19
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2007-11-19
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2007-11-19
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2018-01-09
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2007-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATRION CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1000324175	Halkey-Roberts Corporation	Saint Petersburg, FL, US
1649914	QUEST MEDICAL, INC.	ALLEN, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K951256	Target Therapeutics	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	1995-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857

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2529846	MED SAVER, INC.	PHOENIXVILLE, PA, US
3003790304	GYRUS ACMI, INC.	Westborough, MA, US
9615857	INSTRUMENTARIUM SURGICAL CORP., INC.	TERREBONNE Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043729. Last updated year: 2026. Please use registration number 1043729 when referencing this establishment in official correspondence.