Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040099838

FEI Number

3040099838

Entity Name

FLOWPHYSIX, INC.

City/State/Country

West Lake Hills, TX, US

Establishment Address

1120 S Capital Of Texas Hwy, West Lake Hills, TX 78746, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

FlowPhysix, Inc. (Owner Number: 10095413)

Owner / Operator Contact Address

1120 South Capital of Texas Highway, Austin, TX 78746, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251488

PMA Number

N/A

All Registered Proprietary Names

FLOWRUNNER Aspiration System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-11
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2026-03-11

Official Correspondent

Shiva Ardakani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FlowPhysix, 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
K792141	Pharmaseal Div., Baxter Healthcare Corp.	CONTINUOUS FLUSH DEVICE	1979-12-05
K924661	Baxter Healthcare Corp	SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER	1993-04-08
K232458	ABBOTT MEDICAL	JETiHydrodynamic Thrombectomy System	2023-12-19
K243549	ABBOTT MEDICAL	JETi Hydrodynamic Thrombectomy System	2025-04-04

Similar Registrations

Registration Number	Establishment Name	Location
3038791046	LIQUET MEDICAL INC.	Glen Allen, VA, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3026567963	ENDOVASCULAR ENGINEERING, INC.	Menlo Park, CA, US
3021067373	VVT MED Ltd	Kfar Saba Central, IL
3019525998	VASCUPATENT MEDICAL (SHENZHEN) CO., LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040099838. Last updated year: 2026. Please use registration number 3040099838 when referencing this establishment in official correspondence.