Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011752740

FEI Number

3011752740

Entity Name

AGILE MV

City/State/Country

Montreal Quebec, CA

Establishment Address

3700 rue Saint-Patrick, suite 102, Montreal Quebec H4E 1A2, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Resonetics, LLC (Owner Number: 10078190)

Owner / Operator Contact Address

26 Whipple Street, Nashua, NH 03060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AcQRef Introducer Sheath NAJA Gastrointestinal Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-12-16
FGD	Catheter, Retention, Barium Enema With Bag	Gastroenterology, Urology	Class 2	876.5980	2025-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

Andrea Nicolaisen Business: Resonetics Email: anicolaisen@resonetics.com Phone: (978) 3763504

Related Public Records

Same Entity

Resonetics, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004579081	MEMRY CORPORATION	Bethel, CT, US
3015192261	Resonetics, LLC	Or Akiva Central, IL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Similar Registrations

Registration Number	Establishment Name	Location
3017689643	CARDIOVIA Ltd.	Nazareth Northern, IL
3041086754	PULNOVO MEDICAL (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011752740. Last updated year: 2026. Please use registration number 3011752740 when referencing this establishment in official correspondence.