Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015910259

FEI Number

3015910259

Entity Name

Medline Industries (NAMIC Division) - Glen Falls

City/State/Country

Glens Falls, NY, US

Establishment Address

10 Glen Falls Technical Park Drive, Glens Falls, NY 12801, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medline Industries, LP (Owner Number: 1417592)

Owner / Operator Contact Address

Three Lakes Drive, Northfield, IL 60093, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K843726

PMA Number

N/A

All Registered Proprietary Names

The Grip Torque Device NAMIC Perceptor Manifold NAMIC Standard Angiographic Kit NAMIC Saver-7; Angiographic Control Syringe NAMIC Acceler-8; Angiographic Control Syringe NAMIC Contrast Injection Line NAMIC Perceptor Compensator Manifold NAMIC Tri-Adaptor NAMIC Y-Adaptor NAMIC Tri-Adaptor Kit NAMIC Y-Adaptor Kit Navilyst Medical Convenience Kit Medline Angiography/Angioplasty Kit NAMIC Perceptor DT Monitoring Kit NAMIC Perceptor DT Standard Pole Mount Kit NAMIC Perceptor DT Pressuring Monitoring Kit NAMIC Perceptor DT Disposable Transducer NAMIC Mounting Bracket/Plate NAMIC DT Clamp NAMIC MLL-RA Adaptor NAMIC Manifold Clamp NAMIC Standard Peripheral Vascular Angiographic Kit NAMIC Angiographic Pressure Monitoring Manifolds NAMIC Angiographic Manifold NAMIC Standard Angiographic Kit NAMIC Stopcock NAMIC Torque Device NAMIC Guidewire Introducer NAMIC Stopcock NAMIC Port Protector Medline Cardiovascular Procedure Kit TD2 Torque Device NAMIC POLYCARBONATE SYRINGE NAMIC Control Syringes AVENUE Insertion Tool NAMIC Pediatric Pressure Monitoring Lines NAMIC Adaptor NAMIC Pressure Monitoring Lines Angio-SAC Collection System NAMIC Angiographic Bags

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2019-11-04
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-11-04
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2019-11-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-10-24
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-11-04
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-11-12
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2008-07-09
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-11-04
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2019-10-24
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-22
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2019-11-04
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-22
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2008-07-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-12
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-11-12
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2019-10-24
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-04
DRI	Monitor, Line Isolation	Cardiovascular	Class 1	870.2620	2019-11-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2019-10-22

Official Correspondent

Stephanie Augsburg

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medline Industries, LP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007128716	Medline Industries, LP	Norristown, PA, US
3036706541	EXCELSIOR MEDICAL LLC	Tinton Falls, NJ, US
3016073670	Medline Logistics Japan G.K.	Nishihocho, Aisai-shi Aichi, JP
3006581049	MICROTEK MEDICAL MALTA LIMITED	Mosta, MT
3010389834	Microtek Medical B.V. Varsseveld	VARSSEVELD Gelderland, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08
K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015910259. Last updated year: 2026. Please use registration number 3015910259 when referencing this establishment in official correspondence.