Helo Max Thrombectomy System (HEL2090)
Device Facts
| Record ID | K261800 |
|---|---|
| Device Name | Helo Max Thrombectomy System (HEL2090) |
| Applicant | Endovascular Engineering |
| Product Code | QEW · Cardiovascular |
| Decision Date | Sep 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Hēlo Max Thrombectomy System is indicated for: • The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature. • The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. The Hēlo MAX Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism.
Device Story
Minimally invasive aspiration catheter system; used for mechanical thrombectomy in pulmonary arteries and peripheral veins. System includes aspiration catheter with integrated handle, mechanical agitator, rotating hemostatic valve (RHV), and dilator. Operates by connecting to external vacuum pump; agitator mechanically disrupts emboli within catheter lumen during aspiration. Used by interventional cardiologists, radiologists, and vascular surgeons in clinical settings. Catheter expands to 11 mm distal diameter; compatible with 0.035"/0.038" guidewires. Output is removal of thrombus from vasculature. Healthcare providers use fluoroscopic guidance to navigate and position device; aspiration removes clot, potentially improving patient hemodynamics and reducing pulmonary embolism symptoms.
Clinical Evidence
No human clinical data provided. Evidence consists of bench testing (simulated use, tensile, torque, flow rate, clot aspiration, corrosion, heat generation, particulate, radial force) and a 30-day chronic non-GLP animal study. Biocompatibility (ISO 10993-1) and electrical safety/EMC (IEC 60601-1/2) testing confirmed safety.
Technological Characteristics
20F aspiration catheter; 6V battery-powered agitator; hydrophilic coating; EO sterilized (ISO 11135). Materials biocompatible per ISO 10993-1. Connectivity: connects to external vacuum pump. Dimensions: 90cm working length, 11mm distal expansion. Packaging validated per ASTM F1886, F2096, F88.
Indications for Use
Indicated for adults requiring non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature; allows for injection, infusion, and aspiration of fluids; intended for peripheral veins and pulmonary embolism treatment.
Regulatory Classification
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Predicate Devices
- Helo Thrombectomy System (K252956)
Reference Devices
- Inari/Stryker FlowTriever Retrieval/Aspiration System (K211013)
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
September 3, 2026
Endovascular Engineering
Ishita Raje
Regulatory Affairs Manager
3925 Bohannon Dr., Suite 300
Menlo Park, California 94025
Re: K261800
Trade/Device Name: Hēlo Max Thrombectomy System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy Catheter
Regulatory Class: Class II
Product Code: QEW, KRA
Dated: August 4, 2026
Received: August 4, 2026
Dear Ishita Raje:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
KRINA M.
PATEL -S
Digitally signed by
KRINA M. PATEL -S
Date: 2026.09.03
09:05:15 -04'00'
For,
Gregory O'Connell
Assistant Director
DHT2C: Division of Coronary and
Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261800 | ? |
| Please provide the device trade name(s). | | ? |
| Hēlo Max Thrombectomy System | | |
| Please provide your Indications for Use below. | | ? |
| The Hēlo Max Thrombectomy System is indicated for: • The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature. • The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels. The Hēlo MAX Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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endovascular engineering
K261800
# 510(k) SUMMARY
# for the
# Helo Max Thrombectomy System
# I. SUBMITTER
Name:
Address:
Endovascular Engineering
3925 Bohannon Drive, Suite 300
Menlo Park, CA 94025, USA
Contact:
Telephone:
Email:
Ishita Raje, Regulatory Affairs
Manager 857-300-8852
iraje@e2helo.com
Date Prepared:
August 3, 2026
# II. DEVICE
Name of Device:
Common or Usual Name:
Classification Name:
Hēlo Max Thrombectomy System
Thrombectomy Catheter
Peripheral Mechanical Thrombectomy
with Aspiration
Regulatory Class:
Regulation Number:
Product Code:
II
21 CFR 870.5150
QEW (primary), KRA
# III. PREDICATE DEVICE
Primary Predicate Device:
Endovascular Engineering Helo
Thrombectomy System (K252956)
Reference Predicate
Inari/Stryker FlowTriever
Retrieval/Aspiration System (K211013)
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# IV. DEVICE DESCRIPTION
The Hēlo MAX Thrombectomy System (Helo Max) is a minimally invasive aspiration catheter with an integrated handle. It can be initially introduced with a 20 or 22 Fr introducer sheath and expands to 11 mm at the distal portion once inside the vasculature. The Helo Max allows for engagement with the targeted clot, ingestion of the targeted clot, and transportation of ingested clot out of the body. The Helo Max is supplied sterile using Ethylene Oxide gas and is intended for single-use only. The Helo Max is comprised of the following components:
- Aspiration Catheter: The Aspiration Catheter includes a funnel, an outer sleeve, and an integrated handle with controls. The handle also features a side port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter, and for measurement
of intravascular pressure using a standard pressure line setup, if needed. A second side port is used to purge air from the outer sleeve prior to use. The Aspiration Catheter is compatible with a 0.035" or 0.038" guidewire. It connects to a commercially available vacuum pump.
- Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter. It includes a drive unit that connects to the proximal end of the Aspiration Catheter. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter during use.
- Rotating Hemostatic Valve (RHV): The RHV is an accessory that can be attached to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy Borst valve to enable compatibility and sealing on ancillary devices, such as guidewires.
- Dilator: The 14F diameter, 119cm Dilator is an accessory that is compatible with 0.035" or 0.038" guidewires and can be used to facilitate navigation through the heart.
# V. INDICATIONS FOR USE
The Hēlo Max Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature.
- The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.
The Hēlo Max Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism.
# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Helo Max is a larger diameter configuration of the Helo Thrombectomy System which was evaluated in the ENGULF IDE study for the treatment of pulmonary embolism.
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endovascular engineering
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Performance testing and pre-clinical animal testing were used to establish substantial equivalence to the predicate device.
The Inari FlowTriever device was selected as a reference predicate for the catheter device size (Triever 20). The Helo Max incorporates similar design features, procedural steps, and performance characteristics when compared to the primary and reference predicate devices. All 3 devices are single-use, disposable, catheter-based technologies that are provided sterile by EO.
| Characteristic | Subject Device | Primary Predicate | Reference Predicate |
| --- | --- | --- | --- |
| Name and 510(k) # | Helo Max Thrombectomy System K261800 | Helo Thrombectomy System K252956 | Triever 20F System K211013 |
| Manufacturer | Endovascular Engineering, Inc. | Endovascular Engineering, Inc. | Inari Medical, Inc./Stryker |
| Classification | II | II | II |
| Classification Name | Peripheral Mechanical Thrombectomy with Aspiration | Peripheral Mechanical Thrombectomy with Aspiration | Peripheral Mechanical Thrombectomy with Aspiration |
| Regulation Number | 870.5150 (Embolectomy catheter) | 870.5150 (Embolectomy catheter) | 870.5150 (Embolectomy catheter) |
| Product Code | QEW, KRA | QEW, KRA | QEW, KRA |
| Intended Use | Emboli and thrombus removal | Emboli and thrombus removal | Emboli and thrombus removal |
| Intended User | Interventional cardiologists, radiologists and vascular surgeons | Interventional cardiologists, radiologists and vascular surgeons | Interventional cardiologists, radiologists and vascular surgeons |
| Target Anatomy | Peripheral blood vessels and pulmonary arteries | Peripheral blood vessels and pulmonary arteries | Peripheral arterial and venous systems and pulmonary arteries |
| Guidewire compatibility | 0.035" - 0.038" | 0.035" - 0.038" | 0.035" |
| Guidewire access | OTW | OTW | OTW |
| Dilator included | Separate dilator packaged with device | Separate dilator packaged with device | Preloaded dilator |
| Outer diameter | 20F | 16F | 16F, 20F, 24F |
| Catheter working length | 90cm | 95cm | 90cm |
| Hydrophilic coating | Yes | Yes | Yes |
| Battery Voltage | 6V | 6V | N/A |
| Has a Rotating Hemostatic Valve | Yes | Yes | No |
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| Characteristic | Subject Device | Primary Predicate | Reference Predicate |
| --- | --- | --- | --- |
| Contains a clot disrupter component | Yes | Yes | Yes |
| Utilizes suction to engage and remove clot | Yes | Yes | Yes |
| Mechanism of Action | Mechanical removal and aspiration of thrombus using a vacuum pump for suction. The Agitator wire can be removed and wiped down to remove wrapped clot clogging the blocked thrombus. | Mechanical removal and aspiration of thrombus using a vacuum pump for suction. The Agitator wire can be removed and wiped down to remove wrapped clot clogging the blocked thrombus. | Triever Catheters are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. |
| Minimum vacuum source (at Sea Level) | -27 inHg (-91.5 kPa) | -27 inHg (-91.5 kPa) | N/A |
| Radiopacity | Visible under fluoroscopy | Visible under fluoroscopy | Visible under fluoroscopy |
| How provided | Sterile, single use, disposable | Sterile, single use, disposable | Sterile, single use, disposable |
| Sterilization Method and packaging | EO sterilized. Single sterile barrier system with protective packaging outside. | EO sterilized. Single sterile barrier system with protective packaging outside. | EO sterilized. Single sterile barrier system with protective packaging outside |
| Shelf life | 6 months | 12 months | Unknown |
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endovascular engineering
K261800
# VII. PERFORMANCE DATA
Bench studies indicate that the Helo Max performs as intended. The testing was performed in conformance with design inputs and input from risk management, national and international standards, and FDA feedback. Testing included:
- Simulated Use
- Tensile
- Torque
- Flow Rate
- Clot Aspiration
- Corrosion
- Heat Generation
- Particulate
- Radial Force Testing
# Sterilization Validation
Sterilization validation was performed on the Helo Max in accordance with ISO 11135 and demonstrated a sterility assurance level of 10⁻⁶.
# Biocompatibility Testing
Biocompatibility testing was conducted in accordance with ISO-10993-1 requirements. The results demonstrated no chemical, toxicological, or safety risks associated with the Hēlo System components, manufacturing processes, or sterilization method. The device is considered biocompatible for its intended use. Testing encompassed the following:
- Cytotoxicity
- Sensitization
- Acute systemic toxicity
- Material Mediated Pyrogenicity
- Intracutaneous Reactivity
- Hemolysis
- Complement Activation
- Thrombogenicity
# Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety and EMC testing were conducted on the Helo Max and demonstrated compliance with IEC 60601-1 and IEC 60601-2 standards.
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# Shelf-Life and Packaging
The Helo Max has a shelf life validated for 6 months. Packaging integrity was confirmed after transportation testing. The following packaging integrity testing was performed:
- Visual Inspection for damage to shipper box, shelf cartons and labels
- Visual Inspection per ASTM F1886/1886M-16
- Gross Leak per ASTM F2096-11
- Seal Strength per ASTM F88-21
# Animal Testing
The Helo Max was subjected to a controlled, 30-day chronic non-GLP animal study that confirmed the device did not raise questions related to safe use.
# VIII. CONCLUSIONS
The Helo Max is substantially equivalent to the predicate device with respect to intended use, principles of operation, technological characteristics, anatomical site, and performance characteristics. Based on the performance, and animal testing it has been demonstrated that the Helo Max System performs as intended and does not raise any new questions of safety and effectiveness when compared with the predicate devices.
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