QUEST MEDICAL, INC.

Registration Details

Registration Name: QUEST MEDICAL, INC.
Registration Number: 1649914
FEI Number: 3001665800
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 1 Allentown Pkwy
City: ALLEN
State: TX
ZIP: 75002
Country: US

Regulatory Submissions

510(k) Number: K953838

Owner / Operator

Firm Name: ATRION CORP.
Operator Number: 9914015
Address: ONE ALLENTOWN PKWY., --
City: Allen
State: TX
Postal Code: 75002
Country: US

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Heat-Exchanger, Cardiopulmonary Bypass	DTR	Class 2	Cardiovascular	No	2007-11-19
Suction Control, Intracardiac, Cardiopulmonary Bypass	DWD	Class 2	Cardiovascular	No	2000-06-12
Set, Administration, Intravascular	FPA	Class 2	General Hospital	No	2017-03-24
Lacrimal Stents And Intubation Sets	OKS	Class U	Unknown	No	2012-11-14
Controller, Temperature, Cardiopulmonary Bypass	DWC	Class 2	Cardiovascular	No	2020-06-25
Snare, Surgical	GAE	Class 1	General, Plastic Surgery	No	2003-05-14
Hook, Ophthalmic	HNQ	Class 1	Ophthalmic	No	2018-06-12
Probe, Lachrymal	HNL	Class 1	Ophthalmic	No	2003-05-14
Detector, Bubble, Cardiopulmonary Bypass	KRL	Class 2	Cardiovascular	No	2009-06-30
Gauge, Pressure, Coronary, Cardiopulmonary Bypass	DXS	Class 2	Cardiovascular	No	2009-06-30
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	Class 2	Cardiovascular	No	2009-06-30
Transducer, Blood-Pressure, Extravascular	DRS	Class 2	Cardiovascular	No	2009-06-30
Tubing, Fluid Delivery	FPK	Class 2	General Hospital	No	2017-10-17
Cpb Check Valve, Retrograde Flow, In-Line	MJJ	Class 2	Cardiovascular	No	2009-05-19
Stopcock, I.V. Set	FMG	Class 2	General Hospital	No	2008-01-25
Administration Set Securement Device	PUK	Class 1	General Hospital	No	2020-04-06
Instruments, Surgical, Cardiovascular	DWS	Class 1	Cardiovascular	No	2003-05-14
Dilator, Lachrymal	HNW	Class 1	Ophthalmic	No	2002-07-26
Device, Intravascular Catheter Securement	KMK	Class 1	General Hospital	No	2022-11-04
Stand, Infusion	FOX	Class 1	General Hospital	No	2001-04-11

Proprietary Names

MPS Myocardial Protection System RLV VALVES VRV Q2 Low Pressure Power Injection Extension Set Q2 IV Extension Set Lacrimal Intubation Set Model LIS27T STENTube Lacrimal Intubation Set Model LIS052 Q-Flex, Q2 Robersite (Registered) Needlefree Injection Site Valve MPS 3 Myocardial Protection System Q2 Blood Administration Sets RETRACT-O-TAPE(R) VASCULAR LOOPS Crawford Hook; Dandy Nerve Hook Lacrimal Intubation Set, Crawford Type MPS Backup System (MPBUS) Q2® Multiport IV Administration Sets and Extension Sets Checkmate® IV Administration Sets and Extension Sets Exoflex IV Extension Sets VCC Multiport Checkmate Velano Vascular Q2® Extension Set Retroguard Arterial Safety Valve Q2 Stopcock Qlinch Securement Band MPS2 Myocardial Protection System Lyka PORT Needle Free Access Device Q2 T-extension set LacriCATH Lacrimal Duct Catheters, Models LDC213T, LDC315T, LDC508T AORTIC PUNCH CleanCut; PerfectCut Precision Delivery Infusion Sets MPS 3 ND Myocardial Protection System LACRICATH LACRICATH LACRIMAL DUCT CATHETER MiniGuard Arterial Safety Valve Tie-V IV Securement STAND INFUSION ASV Sets Myocardial Protection System (MPS) 2

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)