EMBOLX INC.

FDA Device Registration & Listing · Sunnyvale, CA, US · Registration 3011660785

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
3011660785
FEI Number
3011660785
Entity Name
EMBOLX INC.
City/State/Country
Sunnyvale, CA, US
Establishment Address
530 Lakeside Dr Ste 150, Sunnyvale, CA 94085, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Embolx Inc. (Owner Number: 10049613)
Owner / Operator Contact Address
530 Lakeside Dr Ste 150, Sunnyvale, CA 94085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K142692
PMA Number
N/A

All Registered Proprietary Names

Soldier Microcatheter Embolx Microcatheter Embolx Microcatheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2026-01-09
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2018-06-18
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2015-06-29

Official Correspondent

Michael Allen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Embolx 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
K151126 Colibri Technologies, Inc. Foresight Intracardiac Echocardiography (ICE) System 2015-12-18
K931629 Carapace, Inc. CARAPACE ANGIOGRAPHY TRAYS 1993-12-06
K823758 Access Devices, Inc. CENTRAL VEIN CATHERIZATION KIT 1983-02-23
K192019 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 2019-11-08
K230411 ABBOTT MEDICAL Dragonfly OpStar™ Imaging Catheter 2023-04-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2009 Edwards Lifesciences, LLC 2
Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011660785. Last updated year: 2026. Please use registration number 3011660785 when referencing this establishment in official correspondence.
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