Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

K252392 · Perfuze, Ltd. · NRY · Aug 29, 2025 · Cardiovascular

Device Facts

• Record ID: K252392
• Device Name: Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set
• Applicant: Perfuze, Ltd.
• Product Code: NRY · Cardiovascular
• Decision Date: Aug 29, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Millipede™ Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. The Perfuze Aspiration Tube Set is indicated to connect the Millipede™ Aspiration Catheter to a compatible aspiration pump.

Device Story

Millipede™ Aspiration Catheter is a single-lumen, reinforced, variable-stiffness catheter used for neurovascular thrombus removal via direct aspiration. Input: vacuum pressure from a compatible aspiration pump. Operation: catheter navigated through vasculature over a guidewire to the occlusion site; aspiration applied via Perfuze Aspiration Tube Set to remove thrombus. Output: thrombus extraction. Used in clinical settings (e.g., neuro-interventional suites) by physicians. Output visualization via fluoroscopy (radiopaque marker). Benefits: revascularization of occluded intracranial vessels in acute ischemic stroke patients.

Clinical Evidence

No clinical data was conducted. Substantial equivalence is supported by non-clinical bench performance testing.

Technological Characteristics

Single-lumen, reinforced (braid/coil) catheter with hydrophilic coating. Distal outer diameter 0.0837", proximal 0.0865". Includes rotating hemostasis valve. Perfuze Aspiration Tube Set includes flexible braided tubing with luer-lock and suction connectors. Sterile, single-use, EO sterilized.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, and vertebral arteries) within 8 hours of symptom onset. Candidates include those ineligible for or non-responsive to IV thrombolytic therapy.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 29, 2025

Perfuze Ltd.
Anne-Marie Gannon
Director of Regulatory Affairs
Unit 6, Galway Business Park, Dangan,
Galway, H91 W7CP,
Ireland

Re: K252392
Trade/Device Name: Millipede™ Aspiration Catheter; Perfuze Aspiration Tube Set
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: NRY
Dated: July 31, 2025
Received: July 31, 2025

Dear Anne-Marie Gannon:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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K252392 - Anne-Marie Gannon
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality 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 (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 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K252392 - Anne-Marie Gannon
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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).

Sincerely,

Naira Muradyan -S

Naira Muradyan, PhD
Assistant Director
DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252392 | |
| Device Name Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | |
| Indications for Use (Describe) Millipede70 Aspiration Catheter The Millipede70 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment. Perfuze Aspiration Tube Set The Perfuze Aspiration Tube Set is indicated to connect the Millipede70 Aspiration Catheter to a compatible aspiration pump. | |
| Type of Use (Select one or both, as applicable) ☑ 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 [e-mail] | |
| "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." | |

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510(k) Summary – K252392

## Submitter Information

Submitter's Name: Perfuze Ltd.
Address: Unit 6, Galway Business Park, Dangan, Galway, H91 W7CP, Ireland
Contact Person: Anne-Marie Gannon
Telephone: [phone]
Date Prepared: 31 July 2025

## Subject Device

Proprietary Name: Millipede⁷⁰ Aspiration Catheter; Perfuze Aspiration Tube Set
Common/Usual Name: Percutaneous Catheter
Classification Name: Catheter, Thrombus Retriever
Regulatory Class: II
Regulation: 21 CFR 870.1250
Product Code: NRY

## Predicate Device

Proprietary Name: Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
Common/Usual Name: Percutaneous Catheter
Classification Name: Catheter, Thrombus Retriever
Regulatory Class: II
Regulation: 21 CFR 870.1250
Product Code: NRY
Manufacturer: Perfuze Ltd.
510(k) Number: K250012

## Device Description

The Millipede⁷⁰ Aspiration Catheter is a sterile single-use device. It consists of the catheter and a rotating hemostasis valve (RHV).

The catheter is a single lumen, reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The RHV is assembled onto the hub of the catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of devices into the Millipede⁷⁰ Aspiration Catheter.

The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede⁷⁰ Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter.

For the aspiration source, the Millipede⁷⁰ Aspiration Catheter is used in conjunction with a compatible aspiration pump with prespecified performance parameters. The aspiration pump is connected using the Perfuze Aspiration Tube Set along with a legally marketed canister and accessories kit.

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# Indications for Use

Millipede™ Aspiration Catheter

The Millipede™ Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.

Perfuze Aspiration Tube Set

The Perfuze Aspiration Tube Set is indicated to connect the Millipede™ Aspiration Catheter to a compatible aspiration pump.

## Comparison to the Predicate Device

| Attribute | Predicate Device Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012) | Subject Device Millipede™ Aspiration Catheter; Perfuze Aspiration Tube Set (K252392) |
| --- | --- | --- |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | Class II | Same |
| Product Code | NRY | Same |
| Indications for use | The Millipede 070 Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Perfuze Aspiration Tube Set is indicated to connect the Millipede 070 Aspiration Catheter to a compatible aspiration pump. | The Millipede™ Aspiration Catheter, with the Perfuze Aspiration Tube Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous thrombolytic drug therapy or who have not responded to thrombolytic drug therapy are candidates for treatment.
The Perfuze Aspiration Tube Set is indicated to connect the Millipede™ Aspiration Catheter to a compatible aspiration pump. |
| Device Description | Single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during | Same |

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| Attribute | Predicate Device Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K250012) | Subject Device Millipede^{70} Aspiration Catheter; Perfuze Aspiration Tube Set (K252392) |
| --- | --- | --- |
| | navigation in the vasculature. A luer fitting on the catheter hub is used for the attachment of accessories. A strain relief at the hub provides kink resistance for the proximal end. | |
| Principle of Operation | Designed to remove thrombus from the neurovasculature using direct aspiration. | Same |
| Techniques for Use | Standard percutaneous, intravascular techniques. | Same |
| Materials | Polymers and metals commonly used in the manufacture of medical devices. | Same |
| Distal Tip | Tapered, soft, flexible. | Same |
| Catheter Wall Construct | Braid and coil reinforcement, with ribbed internal surface at distal end. | Same |
| Coating | Hydrophilic coating | Same |
| Catheter Profile | 6 Fr | Same |
| Inner Diameter | Distal: 0.070 in
Proximal: 0.069 in | Same |
| Outer Diameter | Distal: 0.0835 in
Proximal: 0.0865 in | Distal: 0.0837 in
Proximal: Same |
| Working Length / Effective length | 136 cm | Same |
| Packaged Accessories | Rotating Hemostasis Valve | Same |
| Condition Supplied | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide (EO) | Same |
| Packaging Configuration | Polyethylene terephthalate Tyvek® pouch, polyethylene tube, paperboard packaging card, cardboard carton. | Same |
| Perfuze Aspiration Tubing | 100 in length
Tubing ID = 0.110 in
Pinch clamp valve for vacuum control | Same |

## Non-Clinical Testing

## Performance Testing (Bench)

The subject and predicate devices have the same indications for use, fundamental design, and operating principle.

The subject Millipede $^{70}$ Aspiration Catheter has the same materials as the predicate device. The only difference in design is a change to the maximum outer diameter at the distal end of the subject device, which is increasing from 0.0835" to 0.0837".

The successful completion of the performance testing listed in the table below demonstrates that the subject Millipede $^{70}$ Aspiration Catheter meets the defined design specifications and is suitable for its intended use.

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| Test | Test Method | Conclusions |
| --- | --- | --- |
| Dimensional Verification | The outer diameter of the distal end was measured to confirm conformance to specifications. | The device met established specifications. |
| Simulated Use Testing | Deliverability and compatibility with accessory devices were evaluated in a neurovascular model. | The device performs as intended under simulated use conditions. |
| Visual Inspection | Device surface characteristics were assessed after simulated use testing to confirm freedom from defects that could cause injury. | The device surface characteristics are suitable for its intended use. |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles. | The hydrophilic coating integrity is suitable for its intended use. |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | The device met established specifications. |
| Tip Stiffness | The bending stiffness of the tip was measured to confirm conformance to the specification. | The device met established specifications. |
| Torque Strength | The test specimens were rotated with the distal end constrained from movement to evaluate integrity after rotation. | The device met established specifications. |

The design of the Perfuze Aspiration Tube Set is identical for the subject and predicate devices. Therefore, non-clinical bench testing was not required for the subject Perfuze Aspiration Tube Set.

## Biocompatibility

The materials, formulation, and suppliers of the materials used in the Millipede™ Aspiration Catheter and Perfuze Aspiration Tube Set are identical in the subject and predicate devices. Therefore, no biocompatibility testing was required for the subject device.

## Sterilization

The Millipede™ Aspiration Catheter and Perfuze Aspiration Tube Set are sterilized using a validated EO process with a sterility assurance level of $1 \times 10^{-6}$. The sterilization method is identical for the subject and predicate devices.

## Shelf Life and Packaging

The subject device's shelf life and packaging configuration remain the same as that of the predicate device. Therefore, no shelf-life testing or packaging validation was required to demonstrate substantial equivalence between the subject and predicate devices.

## Animal Study

No animal study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.

## Clinical Data

The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the subject and predicate devices. Therefore, no clinical study was conducted.

## Conclusion

The subject and predicate devices have the same indications for use, fundamental design, operating principle, and materials. The change to the outer diameter at the distal end of the subject Millipede™

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Aspiration Catheter does not raise different questions of safety or effectiveness. The successful completion of bench testing demonstrates that the subject device is substantially equivalent to the predicate device.

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