Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1836324

FEI Number

3002998595

Entity Name

Rose Medical

City/State/Country

Grand Rapids, MI, US

Establishment Address

1440 Front Ave NW, Grand Rapids, MI 49504, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Rose Medical (Owner Number: 10042209)

Owner / Operator Contact Address

1440 Front Avenue NW, Grand Rapids, MI 49504, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CardioGard Emboli Protection Cannula SYNERGY RED IRRAflow CNS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2019-06-07
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2016-10-31
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2012-11-01
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2025-04-07
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	Class 2	876.1725	2025-04-07
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2023-06-07
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-06-07

Official Correspondent

Eric Vroegop

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Rose Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012977275	Rose Medical	Grand Rapids, MI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

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3019807891	CENTERPIECE S. DE R.L DE C.V (sterilization site)	Tijuana Baja California, MX
3009420598	Primo Medical Group, Inc	W Bridgewater, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1836324. Last updated year: 2026. Please use registration number 1836324 when referencing this establishment in official correspondence.