Expanse Medical Inc.

FDA Device Registration & Listing · Pleasanton, CA, US · Registration 3017823876

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017823876
FEI Number
3017823876
Entity Name
Expanse Medical Inc.
City/State/Country
Pleasanton, CA, US
Establishment Address
7060Koll Center Parkway, Suite 300, Pleasanton, CA 94566, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Expanse Medical Inc. (Owner Number: 10088957)
Owner / Operator Contact Address
7060 Koll Center Parkway Suite 300, |Pleasanton, CA, US, 94566
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251488
PMA Number
N/A

All Registered Proprietary Names

FLOWRUNNER Aspiration System FLOWRUNNER Aspiration System SP 7F FLOWRUNNER Aspiration System 7F FLOWRUNNER Aspiration System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-12-09
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-12-09
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2026-05-27
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-05-27
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2025-12-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-12-11

Official Correspondent

Shiva Ardakani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Expanse Medical 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
K241362 Surmodics,Inc. Pounce XL Thrombectomy System (PTS-1011-7F135) 2024-09-11
K220887 Inari Medical Mini-ClotTriever Thrombectomy System 2022-08-04
K250421 Inari Medical, Inc. InThrill™ Thrombectomy System 2025-05-12
K192036 Inari Medical ClotTriever Thrombectomy System 2019-08-29
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05

Similar Registrations

Registration Number Establishment Name Location
3026567963 ENDOVASCULAR ENGINEERING, INC. Menlo Park, CA, US
3015924373 AUSA Medical Device Pvt Ltd Bangalore Karnataka, IN
3015615738 Penumbra Inc. Salt Lake City, UT, US
3029444898 ICHOR VASCULAR INC Brecksville, OH, US
3020347218 Inari Medical, Inc. Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017823876. Last updated year: 2026. Please use registration number 3017823876 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.