Who is the manufacturer of FlowTriever2 Catheter?

Inari Medical, Inc. filed the 510(k) submission for FlowTriever2 Catheter (K250088).

What is the FDA product code for FlowTriever2 Catheter?

QEW. It is classified under 21 CFR 870.5150 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for FlowTriever2 Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FlowTriever2 Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FlowTriever2 Catheter

Q: What are the predicate devices for FlowTriever2 Catheter?

Inari Medical, FlowTriever2 Catheter (K201541).

K250088 · Inari Medical, Inc. · QEW · Mar 13, 2025 · Cardiovascular

Device Facts

Record ID	K250088
Device Name	FlowTriever2 Catheter
Applicant	Inari Medical, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Mar 13, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The FlowTriever2 Catheter is indicated for: · The non-surgical removal of emboli and thrombi from peripheral blood vessels. · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE).

Device Story

FlowTriever2 Catheter is a single-use, sterile embolectomy device for peripheral vasculature and pulmonary embolism treatment. System includes FlowTriever2 Catheter, Triever20/24/16 conduits, and dilator. Principle of operation: catheter advanced over 0.035" guidewire to thrombus site; self-expanding nitinol wireform disk deployed by retracting outer delivery catheter; thrombus captured by manual retraction into Triever conduit; aspiration performed via 60cc syringe. Used in clinical settings by physicians; fluoroscopic visualization aided by radiopaque markers. Output is physical removal of thrombus/emboli. Benefits include minimally invasive clot retrieval, reducing need for surgical intervention. No neurovasculature use.

Clinical Evidence

FLARE-FT2 study: prospective, single-arm, multicenter, 50 patients, 7 sites. Primary safety endpoint: composite of device-related mortality, major bleeding, and intra-procedural adverse events at 48 hours. Primary effectiveness endpoint: change in mean and systolic pulmonary arterial pressure from baseline to post-procedure. Study met all primary performance goals.

Technological Characteristics

Coaxial catheter assembly; outer delivery catheter (Pebax 7233/4033, PTFE liner); inner catheter with distal self-expanding laser-cut nitinol wireform disk. Radiopaque markers (Tungsten/BaSO4). 3.8 mm OD, 120 cm length. 0.035" guidewire compatible. Sterilized via EtO (SAL 10^-6).

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from peripheral blood vessels and treatment of pulmonary embolism (PE) in patients requiring aspiration or fluid infusion/injection.

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

Inari Medical, FlowTriever2 Catheter (K201541)

Related Devices

K191710 — FlowTriever Retrieval/Aspiration System · Inari Medical · Sep 5, 2019
K201541 — FlowTriever Retrieval/Aspiration System · Inari Medical · Dec 4, 2020
K211013 — FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 · Inari Medical, Inc. · Apr 30, 2021
K191368 — FlowTriever Retrieval/Aspiration System · Inari Medical · Jun 17, 2019
K182233 — FlowTriever Retrieval/Aspiration System · Inari Medical · Oct 15, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. March 13, 2025 Inari Medical, Inc. Rayee Patil Regulatory Affairs Specialist 6001 Oak Canyon Suite 100 Irvine, California 92618 Re: K250088 Trade/Device Name: FlowTriever2 Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: January 13, 2025 Received: January 14, 2025 Dear Rayee Patil: 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. {1}------------------------------------------------ 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory {2}------------------------------------------------ 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, Digitally signed by ARIEL G. ASH- ARIEL G. ASH-SHAKOOR -2 SHAKOOR -S Date: 2025.03.13 08:47:06 -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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K250088 Device Name FlowTriever2 Catheter #### Indications for Use (Describe) The FlowTriever2 Catheter is indicated for: · The non-surgical removal of emboli and thrombi from peripheral blood vessels. · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Flow Triever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE). | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" style="margin-right: 0.2em;" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-.052z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:flex; align-items:center;"> <svg class="bi bi-square" fill="currentColor" height="1em" style="margin-right: 0.2em;" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M0 2a2 2 0 0 1 2-2h12a2 2 0 0 1 2 2v12a2 2 0 0 1-2 2H2a2 2 0 0 1-2-2V2zm2-1a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Page 1 of 4 ## 510(k) Summary | Date prepared | March 12, 2025 | | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Name | Inari Medical, Inc. 6001 Oak Canyon, Suite 100 Irvine, CA 92618 877.923.4747 | | | Contact person | Rayee Patil Regulatory Affairs Specialist | | | Trade name | FlowTriever2 Catheter | | | Common name | Embolectomy Catheter | | | Regulation name | Embolectomy Catheter | | | Classification number | 21 CFR 870.5150 | | | Product code | QEW, KRA | | | Regulatory class | II | | | Predicate device(s) | Inari Medical, FlowTriever2 Catheter (K201541) | | | Description | The Inari FlowTriever Retrieval/Aspiration System is a single-use, sterile medical device comprised of the following components, each packaged separately: • FlowTriever2 Catheter - Model 11-102 • Triever20® - Model 21-101 • Triever24® - Model 22-101 • Triever16® - Model 25-101 The FlowTriever2 Catheter is used to engage and retrieve emboli and thrombi. It consists of a coaxial catheter assembly with an outer Delivery Catheter and an inner catheter having a flexible shaft attached to distal self-expanding wireform element. A "Y" connector with a rotatable hemostatic valve and stopcock is attached to the proximal end of the outer Delivery Catheter. Radiopaque markers are positioned near the distal tip of the Delivery Catheter and at the proximal and distal ends of the self-expanding FlowTriever element to aid with fluoroscopic visualization. The Triever20 and Triever24 (packaged separately) provides a conduit for FlowTriever2 Catheter deployment, aspiration, and clot removal. It consists of a single lumen catheter with a proximal hemostasis valve and stopcock with flush port. A radiopaque marker is positioned near the distal tip to aid with fluoroscopic visualization. A Dilator compatible with a 0.035" guidewire is provided for the Triever20 and Triever24 to aid insertion. | | | | Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or 24 Fr) over the pre-inserted guidewire to a location proximal to the targeted thrombus. Thrombus is removed via aspiration using the Triever16, after which it can be withdrawn and flushed to remove residual thrombus, leaving the Triever Catheter in place as a conduit for subsequent thrombectomy passes. The user may elect to perform a thrombectomy pass using the FlowTriever2 Catheter or through the Triever16 using aspiration alone. | | | | The Inari FlowTriever Retrieval/Aspiration System has not been evaluated for use in the neurovasculature. | | | Indications for Use | The FlowTriever2 Catheter is indicated for: | | | | • The non-surgical removal of emboli and thrombi from peripheral blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. | | | | The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism (PE). | | | Device modifications | The purpose of this submission is to expand the indications of the FlowTriever2 Catheter for the treatment of pulmonary embolism. | | | Comparison of Technological Characteristics with Predicate Device | There is no change to the intended use, principles of operation, or fundamental scientific technology between the proposed FlowTriever2 Catheter and the predicate device. | | | Summary of substantial equivalence | A tabular comparison of the predicate and subject devices is provided below: | | | Device | FlowTriever2 Catheter | FlowTriever2 Catheter | {5}------------------------------------------------ | Device | FlowTriever2 Catheter Proposed (K250088) | FlowTriever2 Catheter Predicate (K201541) | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Inari Medical | Inari Medical | | Product code | QEW, KRA | QEW, KRA | | Indications for use | The FlowTriever2 Catheter is indicated for: | The FlowTriever2 Catheter is indicated for: | | | • The non-surgical removal of emboli and thrombi from peripheral blood vessels. | • The non-surgical removal of emboli and thrombi from peripheral blood vessels. | | | • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. | • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. | | | The FlowTriever2 Catheter is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. | The FlowTriever2 Catheter is intended for use in the peripheral vasculature. | | | | | | Principals of Operation | The Triever Catheter (20 or 24 Fr) is placed over a 0.035" guidewire to a location proximal of the target thrombus. The FlowTriever2 Catheter is advanced over the guidewire, through the Triever Catheter to a location with its tip positioned just beyond the thrombus. The self-expanding disk is deployed by manually retracting the outer Delivery Catheter into the Triever Catheter. The FlowTriever2 Catheter is manually retracted inside the Triever Catheter to capture the targeted thrombus. The FlowTriever2 Catheter is removed from the Triever Catheter. Thrombus is aspirated by attaching the Large Bore 60 cc Syringe to the Triever Catheter's side port connector. Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or 24 Fr) over the pre-inserted guidewire to a location proximal to the targeted thrombus. Thrombus is removed via aspiration using the Triever16, after which it can be withdrawn and flushed to remove residual thrombus, leaving the Triever Catheter in place as a conduit for subsequent thrombectomy passes. The user may elect to perform a thrombectomy pass using the FlowTriever2 Catheter or through the Triever16 using aspiration alone. | The Triever Catheter (20 or 24 Fr) is placed over a 0.035" guidewire to a location proximal of the target thrombus. The FlowTriever2 Catheter is advanced over the guidewire, through the Triever Catheter to a location with its tip positioned just beyond the thrombus. The self-expanding disk is deployed by manually retracting the outer Delivery Catheter into the Triever Catheter. The FlowTriever2 Catheter is manually retracted inside the Triever Catheter to capture the targeted thrombus. The FlowTriever2 Catheter is removed from the Triever Catheter. Thrombus is aspirated by attaching the Large Bore 60 cc Syringe to the Triever Catheter's side port connector. Alternatively, the Triever16 can be tracked through the Triever Catheter (20 or 24 Fr) over the pre-inserted guidewire to a location proximal to the targeted thrombus. Thrombus is removed via aspiration using the Triever16, after which it can be withdrawn and flushed to remove residual thrombus, leaving the Triever Catheter in place as a conduit for subsequent thrombectomy passes. The user may elect to perform a thrombectomy pass through the Triever16 using aspiration alone, or in combination with the FlowTriever2 Catheter. | | Vessel Diameters | 6-16 mm | 6-16 mm | | Guidewire compatibility | 0.035" | 0.035" | | Wireform Disk Material | Laser cut nitinol | Laser cut nitinol | | No. of wireform disks | 1 Disk | 1 Disk | | Delivery catheter materials | Proximal - Pebax 7233 SA01 MED, 20% BaSO4 Distal - Pebax 4033 SA01 MED, 20% BaSO4 PTFE Liner…