Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015124694

FEI Number

3015124694

Entity Name

CARDIO FLOW, INC.

City/State/Country

Blaine, MN, US

Establishment Address

3530 88th Ave NE, Blaine, MN 55014, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Cardio Flow, Inc. (Owner Number: 10084699)

Owner / Operator Contact Address

3530 88th Ave NE, Blaine, MN 55014, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213834

PMA Number

N/A

All Registered Proprietary Names

FreedomFlow Orbital Circumferential Atherectomy System FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) FreedomFlow

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-10-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-03-23

Official Correspondent

Darin Busch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cardio Flow, 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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

Registration Number	Establishment Name	Location
3003862657	REX MEDICAL LP	CONSHOHOCKEN, PA, US
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
2011171	Sterigenics US LLC	Los Angeles, CA, US
3012669557	LIGHT GUIDE OPTICS INTERNATIONAL LTD.	Livani Preilu Novads, LV

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015124694. Last updated year: 2026. Please use registration number 3015124694 when referencing this establishment in official correspondence.