Vertex™ Thrombectomy System

K261523 · Jupiter Endovascular · QEW · Aug 4, 2026 · Cardiovascular

Device Facts

• Record ID: K261523
• Device Name: Vertex™ Thrombectomy System
• Applicant: Jupiter Endovascular
• Product Code: QEW · Cardiovascular
• Decision Date: Aug 4, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Vertex Thrombectomy System is indicated for use in the pulmonary arteries for: •The non-surgical removal of emboli and thrombi. •Injection, infusion, and/or aspiration of contrast media and other fluids. The Vertex Thrombectomy System is intended for the treatment of pulmonary embolism.

Device Story

Vertex Thrombectomy System is a catheter-based device for non-surgical removal of pulmonary emboli/thrombi. System includes a Fixation Catheter (26F) with variable stiffness shaft, Aspiration Catheter (20F), and Extraction Set. Operated by physicians in healthcare facilities; catheters introduced over guidewires into pulmonary arteries. Aspiration is achieved via connection to a commercially available vacuum pump. Device enables mechanical thrombus removal and fluid management. Clinical benefit includes reduction of RV/LV ratio in patients with intermediate-risk pulmonary embolism.

Clinical Evidence

Prospective, multicenter, single-arm pivotal study (SPIRARE II) of 123 subjects. Primary safety endpoint: composite of device-related death, major bleeding, and adverse events at 48 hours; rate was 2.4% (p<0.0001 vs 25% goal). Primary effectiveness endpoint: reduction in RV/LV ratio from baseline to 48 hours; mean reduction was 0.39 (95% CI: 0.332, 0.452), exceeding the 0.20 performance goal (p<0.0001).

Technological Characteristics

System comprises 26F Fixation Catheter, 20F Aspiration Catheter, and Extraction Set. Materials include medical-grade plastics and metals. Features variable stiffness shaft, hemostatic valves, and radiopaque markers. Compatible with 0.035" guidewires. Sterilized via Ethylene Oxide (EO). Single-use. No integrated software or electronic sensing.

Indications for Use

Indicated for adults (≥22 years) with pulmonary embolism requiring non-surgical removal of emboli/thrombi from pulmonary arteries or injection/infusion/aspiration of fluids.

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

• Symphony Thrombectomy System (K252057)

Reference Devices

• FlowTriever 24 System (K191710)

Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

August 4, 2026

Jupiter Endovascular
Nicole Barber
Sr. Director, Regulatory Affairs
155 Jefferson Dr.
Menlo Park, California 94025

Re: K261523

Trade/Device Name: Vertex™ Thrombectomy System
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy catheter
Regulatory Class: Class II
Product Code: QEW, KRA
Dated: July 6, 2026
Received: July 6, 2026

Dear Nicole Barber:

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.

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261523 - Nicole Barber

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(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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K261523 - Nicole Barber

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Sincerely,

KRINA M.
PATEL -S

Digitally signed by

KRINA M. PATEL -S

Date: 2026.08.04

15:13:03 -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. | K261523 | ? |
| Please provide the device trade name(s). | | ? |
| Vertex™ Thrombectomy System | | |
| Please provide your Indications for Use below. | | ? |
| The Vertex Thrombectomy System is indicated for use in the pulmonary arteries for: •The non-surgical removal of emboli and thrombi. •Injection, infusion, and/or aspiration of contrast media and other fluids. The Vertex Thrombectomy System is intended for the treatment of pulmonary embolism. | | |
| Please select the types of uses. | ☑ 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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510(k) #: K261523

Jupiter Endovascular - Vertex™ Thrombectomy System

Prepared on: 2026-08-03

# 510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92

## 1 Contact Details: 21 CFR 807.92(a)(1)

| Applicant Name | Jupiter Endovascular |
| --- | --- |
| Applicant Address | 155 Jefferson Dr., Menlo Park, CA 94025 |
| Applicant Contact Telephone | [phone] |
| Applicant Contact | Nicole Barber, Senior Director Regulatory Affairs |
| Applicant Contact Email | [e-mail] |

## 2 Device Name: 21 CFR 807.92(a)(2)

| Trade Name | Vertex™ Thrombectomy System |
| --- | --- |
| Common Name | Embolectomy Catheter |
| Classification Name | Embolectomy Catheter |
| Regulation Number | 870.5150, 870.1210 |
| Product Code(s) | QEW, KRA |

## 3 Legally Marketed Predicate Device: 21 CFR 807.92(a)(3)

Predicate Device: K252057, Imperative Care / Truvic Medical, Inc. Symphony Thrombectomy System

Reference Device: K191710, Inari Medical FlowTriever 24 System

## 4 Device Description Summary: 21 CFR 807.92(a)(4)

The Vertex™ Thrombectomy System is comprised of:

- Vertex Fixation Catheter
- Vertex Aspiration Catheter
- Vertex Extraction Set

The Vertex Fixation Catheter is a single-use catheter having a multilayer shaft with stiffness that is selectively variable between flexible and fixed, a hemostatic valve, and an included obturator (“dilator”). The working length of the catheter is coated to improve lubricity. The handle of the Vertex Fixation Catheter includes a flush line, a fixation line for fixation control, and a hemostatic valve. The catheter shaft and dilator bodies are radiopaque.

The Vertex Aspiration Catheter is a single-use catheter with a hemostatic valve and an included dilator. The handle of the Vertex Aspiration Catheter includes a flush line and a hemostatic valve. The catheter shaft and dilator bodies are radiopaque. The Vertex Aspiration Catheter may be introduced through the Vertex Fixation Catheter.

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510(k) #: K261523

Jupiter Endovascular - Vertex™ Thrombectomy System

Prepared on: 2026-08-03

Either catheter may be used with a commercially available vacuum pump connected via the Vertex Extraction Set to aspirate thrombi. The Vertex Extraction Set includes a distal connector, proximal connector, extraction handle, and clot capture.

## 5 Intended Use/Indications for Use: 21 CFR 807.92(a)(5)

The Vertex Thrombectomy System is indicated for use in the pulmonary arteries for:

•The non-surgical removal of emboli and thrombi.
•Injection, infusion, and/or aspiration of contrast media and other fluids.

The Vertex Thrombectomy System is intended for the treatment of pulmonary embolism.

### Indications for Use Comparison: 21 CFR 807.92(a)(5)

The indications for use for the proposed device are substantially equivalent to the predicate device. Both the subject and the predicate devices are indicated for use in adults undergoing thrombectomy procedures in a healthcare facility; they are intended for use in the treatment of pulmonary embolism.

6 Technological Comparison: 21 CFR 807.92(a)(6)

| Attribute | Subject Device Vertex Thrombectomy System K261523 | Predicate Device Symphony Thrombectomy System K252057 | Reference Device FlowTriever 24 System K191710 |
| --- | --- | --- | --- |
| Product Code | QEW, KRA | QEW, KRA | QEW, KRA |
| Regulation | 21 CFR 870.5150 Embolectomy Catheters | 21 CFR 870.5150 Embolectomy Catheters | 21 CFR 870.5150 Embolectomy Catheters |
| Prescription Use Only | Yes | Yes | Yes |
| Indications for Use | The Vertex Thrombectomy System is indicated for use in the pulmonary arteries for:•The non-surgical removal of emboli and thrombi.•Injection, infusion, and/or aspiration of contrast media and other fluids. The Vertex Thrombectomy System is intended for the treatment of pulmonary embolism. | The Symphony Thrombectomy System is intended for:• The non-surgical removal of fresh, soft emboli and thrombi from blood vessels.• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Symphony Thrombectomy System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. | The FlowTriever Retrieval/Aspiration System is indicated for:• The non-surgical removal of emboli and thrombi from blood vessels.• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. |

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510(k) #: K261523

Jupiter Endovascular - Vertex™ Thrombectomy System

Prepared on: 2026-08-03

| Attribute | Subject Device Vertex Thrombectomy System K261523 | Predicate Device Symphony Thrombectomy System K252057 | Reference Device FlowTriever 24 System K191710 |
| --- | --- | --- | --- |
| Main Components | The Vertex Thrombectomy System is comprised of: - Vertex Fixation Catheter (26F) with dilator - Vertex Aspiration Catheter (20F) with dilator - Vertex Extraction Set | The system is comprised of: - 24F Symphony Catheter - 24F Symphony Standard Dilator - 24F Symphony Advance™ Long Dilator - 24F Symphony ProHelix™ - 16F Symphony Catheter - 16F Symphony Dilator - 16F Symphony ProHelix™ - Symphony Clot Container - TRUVIC Generator - TRUVIC Canister - TRUVIC Tubeset | The system is comprised of: - Triever Catheters (16, 20, and 24 Fr) with dilator - FlowTriever Catheters (6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm) with dilator |
| Principle of Operation | The Vertex Fixation Catheter is intended to be introduced over a guidewire through compatible introducer sheaths. The Vertex Aspiration Catheter may be introduced through the Vertex Fixation Catheter and may be advanced over a guidewire. As needed, the Fixation and Aspiration Catheters may be used with a commercially available vacuum pump connected via the Vertex Extraction Set to aspirate thrombi. | The Symphony Thrombectomy System is designed to remove thrombus/embolus using controlled aspiration. The Symphony Catheter targets aspiration from the TRUVIC Generator directly to the thrombus. The Symphony ProHelix may be used to facilitate aspiration and removal of the thrombus through the Symphony Catheter. | The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. |
| Dimensions | Vertex Fixation Catheter - 26F x 85cm | - 16F x 121 cm - 24F x 85 cm | Triever Catheters: - 16, 20, and 24F x 107, 90, 90 cm |

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510(k) #: K261523

Jupiter Endovascular - Vertex™ Thrombectomy System

Prepared on: 2026-08-03

| Attribute | Subject Device Vertex Thrombectomy System K261523 | Predicate Device Symphony Thrombectomy System K252057 | Reference Device FlowTriever 24 System K191710 |
| --- | --- | --- | --- |
| | Vertex Aspiration Catheter • 20F x 105cm | | FlowTriever Catheters: • 6-10, 11-14, 15-18, and 19-25 mm x 115 cm |
| Guidewire Compatibility | 0.035” | 0.035” | 0.035” |
| Vacuum Source | Aspiration Pump | Aspiration Pump | 60 cc Syringe |
| Sterilization Method | Ethylene Oxide (EO) Sterilization | Ethylene Oxide (EO) Sterilization | Ethylene Oxide (EO) Sterilization |
| Single-Use Disposition | Single-use device | Single-use device | Single-use device |
| Materials | Commonly used medical grade plastics and metals | Commonly used medical grade plastics and metals | Commonly used medical grade plastics and metals |
| Non-Clinical Testing | • Visual and Dimensional Verification • Kink Resistance • Actuation Force • Tensile and Torque Strength • System Freedom from Leakage (positive and negative pressure) • Burst Pressure • Radiodetectability • Simulated Use • Coating Integrity Testing (lubricity) • Particulate Testing • Air Leak • Sheath Stiffness (relaxed state and fixed state) • Obturator Removal Force • Simulated Shipping • Climate Conditioning • Sterile Barrier Integrity | • Visual and Dimensional Verification • Kink / Bend Verification • Actuation Force Verification • Tensile and Torque Strength Verification • Positive Pressure / Fluid Leak Verification • Negative Pressure / Air Leak Verification • Lumen Integrity Verification • Burst Pressure Verification • Fluoroscopy Validation (Visibility test) • Simulated Use Performance Validation • Corrosion Resistance Testing • Coating Integrity Testing • Acute Particulate Testing | • Visual & Dimensional Inspection • Guidewire and Sheath Compatibility Verification • Snap Fit, Dilator Luer to Guide Catheter Hemostasis Valve • Leakage Testing • Vacuum • Air leakage During Aspiration • Retraction Force Testing • Kink Radius Testing • Determination of Flowrate • Burst Testing • Clot Burden Removal Validation • Push Button Force • Simulated Use and Tensile Testing • Simulated Use and Torque |

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510(k) #: K261523

Jupiter Endovascular - Vertex™ Thrombectomy System

Prepared on: 2026-08-03

| Attribute | Subject Device Vertex Thrombectomy System K261523 | Predicate Device Symphony Thrombectomy System K252057 | Reference Device FlowTriever 24 System K191710 |
| --- | --- | --- | --- |
| | | Drop Testing VerificationComponent Fatigue Testing Verification | |
| Biocompatibility | Biocompatibility testing in accordance with ISO 10993-1:CytotoxicitySensitizationIrritation/Intracutaneous ReactivityAcute Systemic ToxicityMaterial Mediated PyrogenicitySterilization residualsHemocompatibility ISO 10993-4:Direct and Indirect HemolysisPartial Thromboplastin TimeComplement ActivationIn vitro Hemocompatibility | Biocompatibility testing in accordance with ISO 10993-1:CytotoxicitySensitizationIntracutaneous ReactivityAcute Systemic ToxicityMaterial Mediated PyrogenicityHemocompatibilityDirect and Indirect HemolysisComplement ActivationIn-Vivo Thrombogenicity (from GLP animal study) | Biocompatibility testing in accordance with ISO 10993-1:MEM elutionISO Guinea Pig Maximization SensitizationISO Intracutaneous IrritationAcute systemic toxicityHemolysis, direct contact and extract methodComplement Activation, C3a and SC5b-9 AssayUnactivated Partial Thromboplastin Time (UPTT) Test (from K180466) |
| Animal Study | A GLP animal study was conducted to confirm the safety and performance of the Vertex Thrombectomy System. A reference device was used for comparative testing. In-vivo thrombogenicity was also assessed | A GLP animal study was performed to assess the acute and chronic safety and performance of the Symphony Thrombectomy System. In-vivo thrombogenicity was also assessed. | Animal testing confirmed the safety and performance of the Triever24 Catheter. |

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510(k) #: K261523

Jupiter Endovascular - Vertex™ Thrombectomy System

Prepared on: 2026-08-03

## 7 Clinical Study

### Introduction

The SPIRARE II study, a prospective, multicenter, single-arm, pivotal clinical investigation, was conducted to evaluate the Vertex Thrombectomy System for the treatment of pulmonary embolism. A total of 123 subjects were enrolled at 19 sites in the United States, Austria, Poland, and Switzerland. The primary effectiveness endpoint was the reduction in RV/LV ratio from baseline to 48 hours or discharge by core lab assessed computed tomography angiography. The primary safety endpoint was the composite of device related major adverse events (MAEs) within 48 hours of the index procedure. Major adverse events were adjudicated for clinical endpoint analysis by an independent clinical events committee (CEC).

### Demographics

Of the 123 enrolled and treated subjects, mean age was \(61 \pm 14\) years; 63 (51%) were male and 60 (49%) were female. Mean body mass index was \(34 \pm 9 \mathrm{~kg} / \mathrm{m}^2\). Cardiovascular comorbidities were reported in 72% of subjects, including hypertension in 59% and hyperlipidemia in 41%. Pulmonary history was reported in 44%, including prior deep vein thrombosis (DVT) in 19%, concomitant DVT at enrollment in 20%, and prior PE in 7%. Baseline disease characteristics reflected intermediate-risk PE severity: mean RV/LV ratio \(1.44 \pm 0.33\), mean Refined Modified Miller Score \(21.79 \pm 3.54\), mean pulmonary artery pressure \(29.6 \pm 6.9 \mathrm{mmHg}\), mean total pulmonary vascular resistance \(6.6 \pm 2.5\) Wood units, mean cardiac index \(2.3 \pm 0.6 \mathrm{~L} / \mathrm{min} / \mathrm{m}^2\), and mean mMRC dyspnea score \(2.72 \pm 1.24\) (with 58% reporting Grade 3 or 4 dyspnea).

### Primary Safety Endpoint

The primary safety endpoint was met. The composite endpoint comprises device-related death; major bleeding (BARC Type 3b, 3c, 5a, 5b, or bleeding requiring blood transfusion); and device-related adverse events including clinical deterioration, pulmonary vascular injury, or cardiac injury. The endpoint was formally tested against a pre-specified performance goal of \(< 25\%\). The 48-hour MAE rate was \(2.4\%\) (3/123); one-sided exact binomial \(\mathrm{p} < 0.0001\).

Composite Safety Endpoint - ITT (N=123)

| Major Adverse Events | 0 to 48 Hours | Comparator | p-value |
| --- | --- | --- | --- |
| Subjects with ≥1 MAE | 3/123 (2.4%) | 25% | <0.0001 |
| Device-related death within 48 hours of the procedure | 0/123 (0%) | | |
| Major bleeding within 48 hours of the procedure | 2/123 (1.6%) | | |
| Device-related adverse events within 48 hours of the procedure | 1/123 (0.8%) | | |
| Clinical deterioration | 1/123 (0.8%) | | |
| Pulmonary vascular injury | 0/123 (0%) | | |
| Cardiac injury | 0/123 (0%) | | |

Results are presented as subjects with events/total subjects (%).

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510(k) #: K261523

Jupiter Endovascular - Vertex™ Thrombectomy System

Prepared on: 2026-08-03

### Primary Effectiveness Endpoint

The primary effectiveness endpoint was met. The reduction in RV/LV ratio from baseline to 48 hours was assessed by CTA and evaluated by an independent core laboratory. The mean RV/LV ratio decreased from \(1.44 \pm 0.33\) at baseline to \(1.05 \pm 0.21\) at 48 hours, with a mean reduction of \(0.39 \pm 0.33\) (95% CI: 0.332, 0.452), evaluated by a one-sided paired t-test against \(\mathrm{H}_0\): mean reduction \(\leq 0.20\) (one-sided \(p < 0.0001\)). The lower bound of the \(95\%\) confidence interval substantially exceeded the 0.20 performance goal.

Reduction in RV/LV Ratio from Baseline to 48 Hours – ITT (N = 123)

| | Baseline | 48 Hours | Change from Baseline to 48 Hours |
| --- | --- | --- | --- |
| RV/LV ratio (CT-based) | \( 1.44 \pm 0.33 \) | \( 1.05 \pm 0.21 \) | \( -0.39 \pm 0.33 \) |
| N | 121 | 122 | 120 |

## Conclusion

All pre-specified performance goals were met, demonstrating substantial equivalence of the Vertex Thrombectomy System for the treatment of acute pulmonary embolism.

## 8 Non-clinical and/or Clinical Tests Summary & Conclusions: 21 CFR 807.92(b)

The Vertex Thrombectomy System has the same intended use as the predicate device. After analyzing technology, materials, bench tests, biocompatibility, animal data, and clinical data, it can be concluded that the Vertex Thrombectomy System is substantially equivalent to the predicate device.

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