Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011427673

FEI Number

3011427673

Entity Name

CARDIOGARD USA, INC

City/State/Country

Tyngsboro, MA, US

Establishment Address

100 Business Park Dr. #5, Tyngsboro, MA 01879, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CardioGard USA, Inc (Owner Number: 10048779)

Owner / Operator Contact Address

100 Business Park Dr. #5, Tyngsboro, MA 01879, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182302

PMA Number

N/A

All Registered Proprietary Names

CardioGard Emboli Protection Cannula

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	2022-04-18

Official Correspondent

Brian Donlon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CardioGard USA, Inc

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

View Entity Profile →

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

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.

Similar Registrations

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3038776570	INVOSURG INC	Canton, MA, US
3009380063	Medtronic Distribution Center	Memphis, TN, US
2916596	THORATEC CORP.	PLEASANTON, CA, US
1836324	Rose Medical	Grand Rapids, MI, US
3019807891	CENTERPIECE S. DE R.L DE C.V (sterilization site)	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011427673. Last updated year: 2026. Please use registration number 3011427673 when referencing this establishment in official correspondence.