Who is the manufacturer of Protrieve Sheath?

Inari Medical, Inc. filed the 510(k) submission for Protrieve Sheath (K230331).

What is the FDA product code for Protrieve Sheath?

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

What is the regulatory pathway for Protrieve Sheath?

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

Who can help prepare an FDA 510(k) submission like Protrieve Sheath?

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.

Protrieve Sheath

Q: What are the predicate devices for Protrieve Sheath?

Intri24 Introducer Sheath (K212392).

K230331 · Inari Medical, Inc. · QEW · Mar 7, 2023 · Cardiovascular

Device Facts

Record ID	K230331
Device Name	Protrieve Sheath
Applicant	Inari Medical, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Mar 7, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ClotTriever Thrombectomy System is indicated for: - The non-surgical removal of thrombi and emboli from blood vessels. - Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

Device Story

Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath for peripheral vasculature. Input: 0.035" guidewire for insertion. Operation: Sheath and dilator inserted over guidewire; distal self-expanding nitinol funnel deployed via slide actuator proximal to target site; dilator removed; endovascular devices (e.g., ClotTriever catheter) advanced through sheath. Output: Conduit for device delivery/removal; aspiration port/60cc syringe for clot aspiration and fluid infusion. Used in clinical settings by physicians under fluoroscopic guidance. Benefits: Facilitates thrombectomy and endovascular procedures while minimizing blood loss via hemostasis valve.

Clinical Evidence

No clinical data. Bench testing only. Verification tests performed for slide actuator modification included simulated use, flushing, leakage, and tensile testing. All acceptance criteria met.

Technological Characteristics

Materials: Pebax 4533/3533, Nitinol (mesh funnel), Platinum-iridium (marker band), HDPE/LDPE/ABS (dilator). Features: Hydrophilic coating, distal self-expanding funnel, aspiration port, hemostasis valve. Dimensions: 0.035" guidewire compatible. Sterilization: EO (SAL 10-6). Connectivity: None.

Indications for Use

Indicated for non-surgical removal of thrombi/emboli from peripheral vasculature (including DVT) and as a conduit for endovascular device insertion/removal while minimizing blood loss. Applicable to patients requiring peripheral vascular intervention.

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

Intri24 Introducer Sheath (K212392)

Reference Devices

Protrieve Sheath (K220415)

Related Devices

K253323 — Protrieve Sheath · Inari Medical · Oct 29, 2025
K233815 — ClotTriever Sheath · Inari Medical, Inc. · Dec 18, 2023
K220415 — Protrieve Sheath · Inari Medical, Inc. · Jul 12, 2022
K223000 — Artix BG · Inari Medical · Jan 11, 2023
K142829 — Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer · Cook Incorporated · Jul 28, 2015

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). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 7, 2023 Inari Medical, Inc. Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine, California 92618 Re: K230331 Trade/Device Name: Protrieve Sheath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA, DYB Dated: February 6, 2023 Received: February 7, 2023 Dear Kaitlyn Weinkauf: 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 {1}------------------------------------------------ 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 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, Digitally signed by Gregory W. Gregory W. O'connell O'connell -S Date: 2023.03.07 13:28:40 -05'00 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) K230331 Device Name Protrieve Sheath Indications for Use (Describe) The ClotTriever Thrombectomy System is indicated for: - · The non-surgical removal of thrombi and emboli from blood vessels. - · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectorny System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| 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}------------------------------------------------ K230331 PAGE 1 OF 6 # 510(K) SUMMARY | Date prepared | March 6, 2023 | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Inari Medical, Inc. 6001 Oak Canyon, Suite 100 Irvine, CA 92618 949-600-8433 | | Contact person | Kaitlyn Weinkauf Sr. Regulatory Affairs Specialist | | Device Name | Protrieve™ Sheath | | Trade Name | Protrieve™ Sheath | | Common name | Embolectomy catheter | | Regulation name | Embolectomy catheter | | Classification number | 21 CFR 870.5150 | | Primary product code | QEW | | Secondary product codes | KRA, DYB | | Regulatory class | II | | Predicate device | Intri24™ Introducer Sheath (K212392) | | Reference device | Protrieve™ Sheath (K220415) | | Description | The Protrieve Sheath is a sterile, single-use over-the-wire introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC). | | Indications for Use | The ClotTriever Thrombectomy System is indicated for: The non-surgical removal of thrombi and emboli from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | devices into the vasculature while minimizing blood loss associated with such insertions. {4}------------------------------------------------ Device modifications The purpose of this submission is a design modification to the Protrieve Sheath slide actuator specifically and to expand the indications for use statement to include using the Protrieve Sheath as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions. There are no proposed changes to the intended use of the Protrieve Sheath. There are no proposed changes to the intended use and design of the ClotTriever/ClotTriever BOLD Catheter and ClotTriever Sheaths (13 Fr and 16 Fr). Comparison of Technological Characteristics with the Predicate Device The predicate Intri24 Introducer Sheath is indicated to "Provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions." The proposed Protrieve Sheath's expanded indications for use are identical. Furthermore, the principles of operation and fundamental scientific technology of the proposed Protrieve Sheath and predicate device are substantially equivalent. Both devices act as a conduit for the insertion and removal of endovascular devices in the vasculature. The design and materials of construction of both devices are also substantially the same. The shafts of both devices contain a hydrophilic coating to reduce the insertion force through skin and tissue. Both sheaths also include an appropriately sized dilator (0.035" guidewire compatible) with a tapered tip to aid in dilation of the target vessel when inserting the sheath. Both sheaths contain a useractuated hemostasis valve that allows for inserting or withdrawing endovascular devices through the sheath while minimizing blood loss. | Device | Protrieve Sheath (Proposed) | Intri24 Introducer Sheath Predicate (K212392) | Protrieve Sheath Reference (K220415) | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Inari Medical | Inari Medical | Inari Medical | | Product Code | QEW, KRA, DYB | DYB | QEW, KRA | | Indications for Use | The ClotTriever Thrombectomy System is indicated for: • The non-surgical removal of thrombi and emboli from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). The Protrieve Sheath is indicated for use as a conduit for the insertion of endovascular devices into the vasculature | The Intri24 Introducer Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions. | The ClotTriever Thrombectomy System is indicated for: • The non-surgical removal of thrombi and emboli from blood vessels. • Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT). | | | | | | | | while minimizing blood loss associated with such insertions. | | | | Device Description | The Protrieve Sheath is a single-use, sterile medical device for use in the peripheral vasculature. The Protrieve Sheath is an introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. | The Intri24 Introducer Sheath is a single-use, sterile medical device for use in the peripheral vasculature. The Intri24 Introducer Sheath is an introducer sheath consisting of a short single lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid with fluoroscopic visualization. The Intri24 dilator is compatible with a 0.035" guidewire and has a tapered leading edge which aids insertion and positioning of the Intri24 Sheath. | The Protrieve Sheath is a single-use, sterile medical device for use in the peripheral vasculature. The Protrieve Sheath is an introducer sheath with a hydrophilic coating, distal self-expanding funnel, aspiration port, and proximal hub. A dilator is provided to aid insertion and positioning of the sheath. Other provided accessories include a 60 cc large bore syringe that provides a vacuum source and collects aspirated contents. Radiopaque markers aid sheath positioning under fluoroscopic visualization. The dilator tip is radiopaque, and there is a radiopaque marker band near the distal end of the sheath. | | Principles of Operation | The Protrieve Sheath and dilator are inserted over a pre-placed 0.035" guidewire into the vessel. Under fluoroscopic guidance, the funnel is deployed proximal to the target site. The Protrieve Sheath funnel is deployed by retracting the sheath's slide actuator back until it snaps into place. Once the funnel is deployed, the dilator is withdrawn through the sheath and from the patient entirely. The ClotTriever/ClotTriever | The Intri24 Introducer Sheath and dilator are inserted over a pre- placed 0.035" guidewire into the vessel towards the target treatment site using fluoroscopic imaging. After positioning, the dilator is detached from the hemostasis valve and withdrawn from the patient. An endovascular device is then advanced over the guidewire through the Intri24 Introducer Sheath to the targeted treatment site. Following the diagnostic or therapeutic procedure, the endovascular device is retracted through the Intri24 Introducer Sheath and removed from the patient. | The Protrieve Sheath and dilator are inserted over a pre- placed 0.035" guidewire into the vessel. Under fluoroscopic guidance, the funnel is deployed proximal to the target site. The Protrieve Sheath funnel is deployed by retracting the sheath's slide actuator back until it snaps into place. Once the funnel is deployed, the dilator is withdrawn through the sheath and from the patient entirely. The ClotTriever/ClotTriever BOLD Catheter is then advanced over the guidewire through the Protrieve Sheath to the targeted treatment site. The ClotTriever/ClotTriever | | | | | | | | endovascular device is then advanced over the guidewire through the Protrieve Sheath to the targeted treatment site. Following the diagnostic or therapeutic procedure, the ClotTriever/ ClotTriever BOLD Catheter or endovascular device is retracted through the Protrieve Sheath and removed from the patient. A 60 cc syringe is provided for the aspiration of clot in the sheath and the infusion of contrast media and other fluids. | | BOLD Catheter with the entrapped clot is retracted through the Protrieve Sheath and removed from the patient. A 60 cc syringe is provided for the aspiration of clot in the sheath and the infusion of contrast media and other fluids. | | Target Vessel | Peripheral vasculature. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC). | Peripheral vasculature. | Peripheral vasculature. Target vessels include, but are not limited to, the iliofemoral, upper and lower extremity, inferior vena cava (IVC), and superior vena cava (SVC). | | Placement duration | < 24 hours | < 24 hours | < 24 hours | | Sterilization | SAL 10-6, EO | SAL 10-6, EO | SAL 10-6, EO | | Shelf-life | 2 years | 2 years | 2 years | | How provided | Sterile, single use | Sterile, single use | Sterile, single use | | Sheath shaft length | Undeployed length: 38 cm Deployed length: 32 cm | 33 cm | Undeployed length: 32 cm Deployed length: 26 cm | | Sheath shaft ID/OD | ID: 0.270" OD: 0.345" | ID: 0.314" OD: 0.344" | ID: 0.270" OD: 0.345" | | Shaft coating | Hydrophilic coating | Hydrophilic coating | Hydrophilic coating | | Sheath Shaft Materials | Proximal segment: Pebax 4533 (45D) SA 01 MED, 4% Violet C Hydrophilic Coating | Proximal segment: Pebax 4533 (45D) SA 01 MED, 20% BaSO4, 4% Violet C, Hydrophilic Coating | Proximal segment: Pebax 4533 (45D) SA 01 MED, 4% Violet C Hydrophilic Coating | | | Distal segment: Pebax 3533 (35D) SA 01 MED, Propel, 4% Violet C | Distal segment: Pebax 6333 (63D) SA 01 MED, 20% BaSO4, 4% Violet C | Distal segment: Pebax 3533 (35D) SA 01 MED, Propel, 4% Violet C | | | | | | | Marker band | Platinum-iridium | Platinum-iridium | Platinum-iridium | | Mesh Funnel | Length: 1.24" OD: 33.5 mm Material: 0.0067" Nitinol wire | N/A | Length: 1.24" OD: 33.5 mm Material: 0.0067" Nitinol wire | | Dilator Materials | HDPE DMDA 8920+, 2% Titanium dioxide LDPE 640i, 20% Barium sulfate, 2% Titanium dioxide ABS, Cool Gray 6C | HDPE DMDA 8920+, 2% Titanium dioxide LDPE 640i, 20% Barium sulfate, 2% Titanium dioxide ABS, Cool Gray 6C | HDPE DMDA 8920+, 2% Titanium dioxide LDPE 640i, 20% Barium sulfate, 2% Titanium dioxide ABS, Cool Gray 6C | | Dilator OD | 0.264" | 0.315" | 0.264" | | Dilator Length | 25.15" | 18.78" | 22.96" | | Sideport Tubing with Stopcock and Quick Connect | Yes | Yes | Yes | | Guidewire compatibility | 0.035" | 0.035" | 0.035"…

Protrieve Sheath

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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Protrieve Sheath

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Reference Devices

Related Devices

Submission Summary (Full Text)

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