Millipede88 Access Catheter
Device Facts
| Record ID | K253901 |
|---|---|
| Device Name | Millipede88 Access Catheter |
| Applicant | Perfuze, Ltd. |
| Product Code | QJP · Cardiovascular |
| Decision Date | Jul 9, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The Millipede88 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
Device Story
Millipede88 Access Catheter is a single-lumen, variable-stiffness, wire-reinforced catheter used in neurovascular procedures. It functions as a guide catheter to facilitate microcatheter delivery. The device includes a rotating hemostasis valve (RHV) and a valve crossing tool. It is operated by physicians using standard percutaneous interventional techniques under fluoroscopic guidance. The distal segment features a hydrophilic coating for navigation. The device is provided sterile (EO) for single use. It maintains hemostasis during saline/contrast infusion and device insertion. Clinical benefit is derived from its ability to provide stable access to target neurovasculature, aiding in the delivery of therapeutic or diagnostic microcatheters.
Clinical Evidence
No clinical data was conducted. Substantial equivalence is supported by bench performance testing, including dimensional inspection, simulated use in neurovascular models, kink resistance, tip stiffness, leak testing, tensile strength, and flow rate characterization. Biocompatibility was verified per ISO 10993-1.
Technological Characteristics
Single-lumen, wire-reinforced (coil/braid) catheter; variable stiffness; hydrophilic coating (500mm distal); radiopaque marker. Materials: polymers and metals. Dimensions: 8 Fr profile, 0.088" ID, 120 cm length. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 10555-1 (leakage/burst), ISO 10993-1 (biocompatibility), ASTM F1980 (shelf life).
Indications for Use
Indicated for facilitating insertion and guidance of microcatheters into selected blood vessels in the neurovasculature.
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 088 Access Catheter (K242504)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
July 9, 2026
Perfuze Ltd.
Jeanine O'Donnell
Principal Regulatory Affairs Specialist
Unit 6, Galway Business Park, Dangan,
Galway, H91 W7CP,
Ireland
Re: K253901
Trade/Device Name: Millipede88 Access Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP
Dated: June 11, 2026
Received: June 11, 2026
Dear Jeanine O'Donnell:
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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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253901 - Jeanine O'Donnell
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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,
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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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*)
K253901
Device Name
Millipede88 Access Catheter
Indications for Use (*Describe*)
The Millipede88 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
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.**
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**\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\***
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740 EF
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# 510(k) Summary – K253901
## Submitter Information
Submitter's Name: Perfuze Ltd.
Address: Unit 6, Galway Business Park,
Dangan,
Galway, H91 W7CP,
Ireland
Contact Person: Jeanine O'Donnell
Telephone: +353 91 428083
Date Prepared: June 11th 2026
## Subject Device
Proprietary Name: Millipede88 Access Catheter
Common/Usual Name: Guide Catheter
Classification Name: Catheter, Percutaneous, Neurovasculature
Regulatory Class: II
Regulation: 21 CFR 870.1250
Product Code: QJP
## Predicate Device
Proprietary Name: Millipede 088 Access Catheter
Common/Usual Name: Guide Catheter
Classification Name: Catheter, Percutaneous, Neurovasculature
Regulatory Class: II
Regulation: 21 CFR 870.1250
Product Code: QJP
Manufacturer: Perfuze Ltd.
510(k) Number: K242504
## Device Description
The Millipede88 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).
The Millipede88 Access 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 valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede88 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede88 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede88 Access Catheter.
## Indications for Use
The Millipede88 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.
The Indications for Use statement for the subject Millipede88 Access Catheter is identical to the predicate device.
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# Comparison to the Predicate Device
The intended use of the subject device is identical to the predicate device. The subject and predicate devices have similar technological characteristics as shown in the following table.
| Attribute | Predicate Device Millipede 088 Access Catheter (K242504) | Subject Device Millipede88 Access Catheter (K253901) |
| --- | --- | --- |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous catheter | Same |
| Classification | Class II | Same |
| Product Code | QJP | Same |
| Indications for Use | The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature. | The Millipede88 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature. |
| Device Description | Single-use, variable stiffness, wire-reinforced catheter with a single lumen. The catheter is comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using metals and polymers. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. | Same |
| Principle of Operation | May be used with support catheters to assist in accessing the target neurovasculature. | Same |
| Techniques for Use | Standard percutaneous, interventional techniques, including access site preparation, introduction of the catheter into the access vessel, advancing the catheter under fluoroscopy, withdrawing the catheter, and closing the access site. | Same |
| Materials | Polymers and metals commonly used in the manufacture of medical devices. | Proximal end of catheter: Same Distal end of catheter: Same polymers and metal reinforcement with changes to the color additives used and the addition of stabilizers. |
| Distal Tip | Soft, flexible. | Same |
| Catheter Wall Construction | Coil and braid reinforced, with ribbed surface at distal section. | Same |
| Coating | Hydrophilic coating on distal 350mm of the catheter | Same hydrophilic coating on distal 500mm of the catheter |
| Catheter Profile | 8 Fr | Same |
| Inner Diameter | Distal: 0.088" Proximal: 0.088" | Same |
| Outer Diameter | Distal: 0.104" Proximal: 0.108" | Same |
| Working Length | 120 cm | Same |
| Packaged Accessories | RHV and Valve Crossing Tool | Identical RHV Valve Crossing Tool with same |
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| Attribute | Predicate Device Millipede 088 Access Catheter (K242504) | Subject Device Millipede88 Access Catheter (K253901) |
| --- | --- | --- |
| | | fundamental design but changes to the materials to incorporate different color additives and the addition of stabilizers. |
| Condition Supplied | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide (EO), Sterility Assurance Level 10^{-6} | Same |
| Packaging Configuration | The catheters are placed in a protective polyethylene tube, mounted with accessory RHV and valve crossing tool onto a cardboard packaging card, placed into a pouch, sealed, and labeled. The sealed pouch and Instructions for Use are placed in a labeled shelf carton box. | The catheters are placed in a protective polyethylene tube, mounted with accessory RHV and valve crossing tool onto a polyethylene packaging card, placed into a pouch, sealed, and labeled. The sealed pouch and Instructions for Use are placed in a labeled shelf carton box. |
| Labelled Shelf Life | 12 months | Same |
### Performance Testing (Bench)
The successful completion of the performance testing listed in the table below demonstrates that the subject Millipede88 Access Catheter meets the defined design specifications and is suitable for its intended use.
| Test | Test Method | Conclusions |
| --- | --- | --- |
| Dimensional Inspection | The device dimensions were measured to confirm conformance to the specifications. | The device met established specifications. |
| Visual Inspection | Device surface characteristics were assessed to confirm freedom from defects that could affect clinical use. | The device surface characteristics are suitable for its intended use. |
| Simulated Use Testing | Deliverability and compatibility with accessory devices were evaluated in a neurovascular model. | The device performs as intended under simulated use conditions. |
| 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. |
| Particulate Recovery | The purpose of this test was to quantify the particulate sizes and counts generated during simulated use of the test article. | The particulate generation was similar to control devices. |
| 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. |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | The device integrity is suitable for its intended use. |
| Liquid Leakage | Tested as per ISO 10555-1:2013 Annex C. | The device integrity is suitable for its intended use. |
| Static Burst | Tested as per ISO 10555-1 Annex F. | The device integrity is suitable for its intended use. |
| Catheter Joint Tensile Testing | The tensile strength was evaluated for the bonds between sections of the catheter. | The device met established specifications. |
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| Test | Test Method | Conclusions |
| --- | --- | --- |
| Torque Strength | The test specimens were rotated with the distal end constrained from movement to evaluate integrity after rotation. | The device met established specifications. |
| Luer Dimensions and Functional Performance | The luer was evaluated for compliance to relevant standards. | The luer on the device is suitable for its intended use. |
| Flow Rate Characterization | The flow rate of saline and a contrast- saline solution was characterized when injected through the catheter. | The flow rate was characterized. |
## Biocompatibility
The subject device includes some material differences compared to the predicate device. To ensure that all new materials were assessed, relevant biocompatibility endpoints were addressed through biocompatibility testing of the subject Millipede88 Access Catheter. The testing was completed in accordance with ISO 10993-1:2018. The table below summarizes the biocompatibility testing completed.
| Test | Results |
| --- | --- |
| Cytotoxicity – ISO MEM Elution | The test article is non-cytotoxic. |
| Sensitization – ISO Guinea Pig Maximization Sensitization Test | The test article did not elicit a sensitization response. |
| Irritation – ISO Intracutaneous Reactivity | Requirements of the ISO intracutaneous reactivity test were met for the test article. |
| Acute Systemic Toxicity – ISO Acute Systemic Injection | Requirements of the ISO acute systemic injection test were met for the test article. |
| Material-Medicated Pyrogenicity | The test article is non-pyrogenic. |
| Hemocompatibility – Complement Activation (SC5b-9) | The test article is not considered to be a potential activator of the complement system. |
| Hemocompatibility – Partial Thromboplastin Time | The test article is not considered to be an activator of the intrinsic coagulation pathway. |
| Hemocompatibility – ASTM Hemolysis | The test article is considered non-hemolytic. |
| Hemocompatibility – Platelet and Leukocyte Count | The test article is not considered to have an effect on platelet and leukocyte concentrations. |
## Shelf Life and Packaging
The subject device has a labeled shelf life of 12 months, which is the same as the predicate device. Accelerated aging based on ASTM F1980 was conducted and device performance was verified by functional and performance testing on the devices conditioned by accelerated aging.
The packaging configuration has been changed compared to the predicate device. Testing was completed to evaluate the performance and stability of the new packaging system for the Millipede88 Access Catheter.
## Sterilization
Both the subject and predicate devices are sterilized using a validated EO process with a sterility assurance level of 1x10⁻⁶. A sterilization qualification was completed to adopt the Millipede88 Access Catheter into an existing validated cycle used for other Perfuze devices. EO residual testing was repeated on the subject Millipede88 Access Catheter to confirm that the design differences and new sterilization cycle did not impact residual EO levels of the device. The testing confirmed that EO residuals were within the limits specified in ISO 10993-7.
## Animal Study
No animal study was deemed necessary to demonstrate substantial equivalence between the subject and predicate devices.
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## 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 indications for use of the Millipede88 Access Catheter are identical to the predicate device. The subject Millipede88 Access Catheter and the predicate device use the same operating principles and have a similar design. The differences identified in this submission do not raise different or new questions of safety or effectiveness. The successful completion of performance and biocompatibility testing demonstrates that the subject Millipede88 Access Catheter is substantially equivalent to the predicate device.
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