Who is the manufacturer of InThrill Thrombectomy System?

Inari Medical, Inc. filed the 510(k) submission for InThrill Thrombectomy System (K223613).

What is the FDA product code for InThrill Thrombectomy System?

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

What is the regulatory pathway for InThrill Thrombectomy System?

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

Who can help prepare an FDA 510(k) submission like InThrill Thrombectomy System?

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.

InThrill Thrombectomy System

K223613 · Inari Medical, Inc. · QEW · Mar 17, 2023 · Cardiovascular

Device Facts

Record ID	K223613
Device Name	InThrill Thrombectomy System
Applicant	Inari Medical, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Mar 17, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The InThrill Thrombectomy System is indicated for: - The non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. The InThrill Thrombectomy System is intended for use in the peripheral vasculature. The InThrill Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment.

Device Story

Single-use, over-the-wire, catheter-based system for peripheral vascular thrombectomy. Comprises InThrill Sheath (with distal self-expanding funnel, proximal aspiration port, hemostatic valve) and InThrill Thrombectomy Catheter (with expandable nitinol coring element/basket). Used in clinical settings by physicians. Sheath funnel expands to occlude flow and secure position; catheter coring element gathers/pulls thrombus toward sheath for aspiration. Radiopaque markers facilitate fluoroscopic positioning. Benefits include minimally invasive removal of organized/adherent thrombus from dialysis access and synthetic grafts. Output is physical removal of embolic material; healthcare provider uses fluoroscopy to guide device and monitor clot extraction.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (graft leak, simulated use, radial force, contact pressure, abrasion, comparative clot removal) and a GLP animal study in peripheral vessels.

Technological Characteristics

Materials: Pebax (55D/63D), PTFE liner, stainless steel coil, nitinol (braided funnel, laser-cut coring element), HDPE/LDPE. Energy: Mechanical (manual actuation). Form factor: 8 Fr sheath/catheter system. Connectivity: None. Sterilization: Ethylene Oxide (EtO) to SAL 10^-6. Software: None.

Indications for Use

Indicated for non-surgical removal of thrombi and emboli from peripheral blood vessels, including arteriovenous fistulae, arteriovenous grafts for dialysis access, and synthetic grafts. Also indicated for injection, infusion, or aspiration of fluids/contrast media. Not for DVT 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

Capture Vascular, MegaVac Mechanical Thrombectomy System (K171493)
Hotspur Technologies, Inc., PTA-Plus PTA Balloon Catheter (K100842)
Inari Medical, Mini-ClotTriever Thrombectomy System (K220887)

Reference Devices

Intramed Laboratories, Inc., Graft Thrombectomy Instruments (K942457)
Rex Medical, Cleaner Rotational Thrombectomy System (K141617)

Related Devices

K220887 — Mini-ClotTriever Thrombectomy System · Inari Medical · Aug 4, 2022
K180329 — ClotTriever Thrombectomy System · Inari Medical, Inc. · Apr 9, 2018
K173470 — ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath · Inari Medical · Dec 4, 2017
K192036 — ClotTriever Thrombectomy System · Inari Medical · Aug 29, 2019
K250421 — InThrill Thrombectomy System · Inari Medical, Inc. · May 12, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below. March 17, 2023 Inari Medical, Inc Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618 ## Re: K223613 Trade/Device Name: InThrill Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 14, 2023 Received: February 14, 2023 ## Dear Ellen Nguyen: 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 (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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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, Gregory W. Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.03.17 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223613 Device Name InThrill Thrombectomy System Indications for Use (Describe) The InThrill Thrombectomy System is indicated for: - The non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous grafts for dialysis access, and synthetic grafts. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graff. The InThrill Thrombectomy System is intended for use in the peripheral vasculature. The InThrill Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {3}------------------------------------------------ ## PAGE 1 OF 6 # 510(K) SUMMARY | Date prepared | March 16, 2023 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Inari Medical, Inc. 6001 Oak Canyon, Suite 100 Irvine, CA 92618 877.923.4747 | | Contact person | Ellen Nguyen Regulatory Affairs Specialist | | Trade name | InThrill Thrombectomy System | | Common name | Embolectomy catheter | | Regulation name | Embolectomy catheter | | Classification number | 21 CFR 870.5150 | | Product code | QEW | | Secondary product code | KRA | | Regulatory class | II | | Predicate device(s) | Capture Vascular, MegaVac Mechanical Thrombectomy System (K171493) Hotspur Technologies, Inc., PTA-Plus PTA Balloon Catheter (K100842) Inari Medical, Mini-ClotTriever Thrombectomy System (K220887) | | Reference device(s) | Intramed Laboratories, Inc., Graft Thrombectomy Instruments (K942457) Rex Medical, Cleaner Rotational Thrombectomy System (K141617) | | Description | The InThrill™ Thrombectomy System is a single-use, sterile medical device designed to remove thrombi and emboli from the peripheral vasculature. The InThrill™ Thrombectomy System consists of the InThrill Sheath ("Sheath") and the InThrill Thrombectomy Catheter ("Catheter"), each packaged separately. The Sheath is an introducer sheath with a distal self-expanding funnel, proximal aspiration port, and proximal hub. A Dilator is provided to aid insertion and positioning of the Sheath. Radiopaque markers aid Sheath positioning under fluoroscopic visualization. The Sheath and Dilator tips are radiopaque, and there is a radiopaque marker band at the proximal end of the Sheath funnel. | | Indications for Use | The InThrill Thrombectomy System is indicated for: The non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. | {4}------------------------------------------------ #### PAGE 2 OF 6 The InThrill Thrombectomy System is intended for use in the peripheral vasculature. The InThrill Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment. Summary of substantial A tabular comparison of the predicate and subject devices is provided below: equivalence | | Subject Device InThrill Thrombectomy System | Primary Predicate MegaVac Mechanical Thrombectomy System | Predicate PTA-Plus PTA Balloon Cather 5mm X 4cm, PTA-Plus PTA Balloon Catheter 6mm X 4cm | Predicate Mini-ClotTriever Thrombectomy System | | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | K Number | K223613 | K171493 | K100842 | K220887 | | | Manufacturer | Inari Medical, Inc. | Capture Vascular, Inc. | Hotspur Technologies, Inc. | Inari Medical, Inc. | | | Regulations | 21 CFR 870.5150 Embolectomy catheter | 21 CFR 870.5150 Embolectomy catheter | 21 CFR 870.5150 Embolectomy catheter 21 CFR 870.1250 Percutaneous catheter | 21 CFR 870.5150 Embolectomy catheter | | | Product Code | QEW KRA | QEW QEX DXE | DXE LIT | QEW | | | Indications for Use | The InThrill Thrombectomy System is indicated for: • The non-surgical removal of thrombi and emboli from blood vessels, including arteriovenous fistulae and arteriovenous grafts for dialysis access, and synthetic grafts. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel/graft. The InThrill Thrombectomy System is intended for use in the peripheral vasculature. | The MegaVac Mechanical Thrombectomy System is indicated for: • The non-surgical removal of emboli and thrombi from blood vessels. • The non-surgical removal of thrombi from synthetic grafts. • Use in temporary blood vessel/graft occlusion. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vessel/graft • Catheter placement over a guidewire | The PTA-Plus PTA Balloon Catheter is indicated for use within synthetic arteriovenous dialysis fistulae to remove embolic material (thrombus/debris) and dilate stenosis for treatment of obstructive lesions. | The Mini-ClotTriever Thrombectomy 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 Mini-ClotTriever Thrombectomy System is intended for use in the peripheral vasculature. The Mini-ClotTriever Thrombectomy System is not intended for use in deep vein thrombosis (DVT) treatment. | | | | The InThrill | The MegaVac | The PTA-Plus PTA | The Mini-ClotTriever | | | | Thrombectomy | Mechanical | Balloon Catheter is | Thrombectomy | | | | System is not | Thrombectomy | designed for de- | System is a single- | | | | intended for use in | System is a single- | clotting and treating | use, over-the-wire, | | | | deep vein thrombosis | use, over-the-wire, | stenosis in synthetic | catheter-based system | | | | (DVT) treatment. | catheter-based system | dialysis fistulae. It is | for the minimally | | | Device | The InThrill | for intravascular | an .035" guide-wire | invasive treatment of | | | Description | Thrombectomy | mechanical | compatible, PTA | thromboemboli in the | | | | System is a single- | thrombectomy, | balloon catheter with | peripheral | | | | use, over-the-wire, | occlusion, aspiration | a proprietary valve | vasculature. The | | | | catheter-based system | and embolectomy in | system which allows | system comprises | | | | for the minimally | the peripheral | injection of contrast | two main | | | | invasive treatment of | vasculature, | and an embolectomy | components | | | | thromboemboli | including grafts. The | coil for mechanical | packaged separately: | | | | (including organized | system comprises | removal of thrombus. | • Mini-ClotTriever | | | | thrombus and | two main | | Sheath (8 Fr) | | | | adherent thrombotic | components: | | • Mini-ClotTriever | | | | material) in the | • MegaVac Catheter | | Catheter (8 Fr) | | | | peripheral | • ThromboWire clot | | The Mini-ClotTriever | | | | vasculature, | retractor | | Sheath is comprised | | | | including | The MegaVac | | of reinforced | | | | arteriovenous fistulae | Catheter with | | polymeric coaxial | | | | and arteriovenous | SafeSeal technology | | sheath shafts | | | | grafts for dialysis | utilizes a silicone | | equipped with a self- | | | | access, and synthetic | coated nitinol braided | | expanding distal | | | | grafts. The system | funnel that expands | | mesh funnel, a | | | | comprises two main | to occlude antegrade | | flush/aspiration port, | | | | components | blood flow proximal | | and a proximal | | | | packaged separately:…