Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008789872

FEI Number

3008789872

Entity Name

REFLOW MEDICAL, INC

City/State/Country

San Clemente, CA, US

Establishment Address

208 Avenida Fabricante, Suite 100, San Clemente, CA 92672, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Reflow Medical (Owner Number: 10034685)

Owner / Operator Contact Address

208 Avenida Fabricante, Suite 100, San Clemente, CA 92672, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K193596

PMA Number

N/A

All Registered Proprietary Names

Spex Support Catheters coraCross speX Catheter Cora Microcatheters Wingman 35 Crossing Catheter Wingman 14 Crossing Catheter Wingman 14C Crossing Catheter Wingman Coronary Crossing Catheter Spur Peripheral Retrievable Stent System Wingman Crossing Catheters

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-04-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-06-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-02-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-11-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-10-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-12-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-10-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-08-22
SEU	Peripheral Temporary And Retrievable Stent System	Cardiovascular	Class 2	870.5110	2025-06-03
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2020-04-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-04-01

Official Correspondent

Angela Lamprey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Reflow 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
3027058844	Reflow Medical	Lake Forest, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008789872. Last updated year: 2026. Please use registration number 3008789872 when referencing this establishment in official correspondence.