ENDOVASCULAR ENGINEERING, INC.

FDA Device Registration & Listing · Menlo Park, CA, US · Registration 3026567963

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
3026567963
FEI Number
3026567963
Entity Name
ENDOVASCULAR ENGINEERING, INC.
City/State/Country
Menlo Park, CA, US
Establishment Address
3925 Bohannon Drive, Suite 300, Menlo Park, CA 94025, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Endovascular Engineering, Inc. (Owner Number: 10087452)
Owner / Operator Contact Address
3925 Bohannon Drive, Suite 300, Menlo Park, CA 94025, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K223891
PMA Number
N/A

All Registered Proprietary Names

Helo Thrombectomy System Helo G1 Thrombectomy 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 2026-01-09
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-01-09
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-03-01
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-03-01

Official Correspondent

Debra Cogan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Endovascular Engineering, 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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026567963. Last updated year: 2026. Please use registration number 3026567963 when referencing this establishment in official correspondence.
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