Route 92 Medical Full Length 046 Access System

K260220 · Route 92 Medical, Inc. · QJP · Sep 16, 2026 · Cardiovascular

Device Facts

• Record ID: K260220
• Device Name: Route 92 Medical Full Length 046 Access System
• Applicant: Route 92 Medical, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Sep 16, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Indications for Use

The Route 92 Medical Full Length 046 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

Device Story

System comprises single-lumen, variable stiffness support and delivery catheters; hydrophilically coated; coil-reinforced. Used by physicians trained in neurovascular interventional techniques to facilitate microcatheter insertion/guidance into neurovascular blood vessels. Operates via manual navigation through vasculature. Output is physical access path for microcatheters. Benefits include improved deliverability and navigation within neurovascular anatomy.

Clinical Evidence

No clinical data. Evidence consists of bench testing including biocompatibility (ISO 10993-1), dimensional verification, tensile strength, kink/torsion resistance, burst testing, and simulated use in a neurovascular model.

Technological Characteristics

Single-lumen, variable stiffness, coil-reinforced catheters. Hydrophilic coating. Materials: polymers and metals. Sterilization: Ethylene oxide (SAL 10^-6) per AAMI TIR28:2016. Standards: ISO 10993-1 (biocompatibility), ISO 80369-7 (luer), ISO 10555-1 (leakage/burst), ASTM F756, F2382, F2888 (hemocompatibility).

Indications for Use

Indicated for patients requiring use of a microcatheter in the neurovascular system to facilitate insertion and guidance of microcatheters into selected blood vessels.

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

• Route 92 Medical Full Length 054 Access System (K231583)

Submission Summary (Full Text)

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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

September 16, 2026

Route 92 Medical, Inc.
Denise Aycox
Regulatory Affairs Manager
155 Bovet Road, Suite 100
San Mateo, California 94402

Re: K260220

Trade/Device Name: Route 92 Medical Full Length 046 Access System
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP
Dated: July 14, 2026
Received: July 16, 2026

Dear Denise Aycox:

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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K260220 - Denise Aycox

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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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K260220 - Denise Aycox

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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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# Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K260220

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Please provide the device trade name(s).

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Route 92 Medical Full Length 046 Access System

Please provide your Indications for Use below.

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The Route 92 Medical Full Length 046 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K260220

| Sponsor: | Route 92 Medical, Inc. 155 Bovet Road, Suite 100 San Mateo, CA 94402 |
| --- | --- |
| Contact: | Denise Aycox Regulatory Affairs Manager [e-mail] Phone: [phone] |
| Date Prepared: | September 8, 2026 |
| Device Name: | Route 92 Medical Full Length 046 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature (Product Code QJP, 21 CFR 870.1250) |
| Device Classification: | Class II |
| Predicate Device: | Route 92 Medical Full Length 054 Access System – K231583 |

### Device Description

The Route 92 Medical Full Length 046 Access System includes a Support Catheter and a Delivery Catheter. The Support Catheter and Delivery Catheter are both single-lumen, variable stiffness catheters. Both catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.

### Indications for Use

The Route 92 Medical Full Length 046 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

### Comparison to the Predicate Device

The method of action, design, and materials of the Route 92 Medical Full Length 046 Access System are equivalent or similar to the Predicate Device as shown in the following table.

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| Attribute | Predicate Device Route 92 Medical Full Length 054 Access System (K231583) | Subject Device Route 92 Medical Full Length 046 Access System (K260220) |
| --- | --- | --- |
| Indications for Use | The Route 92 Medical Full Length 054 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. | The Route 92 Medical Full Length 046 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. |
| Device Description | Sterile, single-use, variable stiffness, coil-reinforced catheter | Same |
| Targeted population | Patients requiring use of a microcatheter in the neurovascular system | Same |
| User | Physicians trained in neurovascular interventional techniques | Same |
| Anatomical Sites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly used in the manufacture of medical devices | Same |
| Sterilization | Ethylene oxide | Same |
| Shelf Life | 6 months | Same |
| **Support Catheter** | | |
| Inner Diameter | 0.054' | 0.046' |
| Outer Diameter | 0.066' | 0.058' |
| Length | 125 cm and 148 cm | 125 cm and 143 cm |
| **Delivery Catheter** | | |
| Inner Diameter | 0.015' | 0.016' |
| Outer Diameter | 0.048' | 0.040' |
| Length | 167 cm | 167 cm |

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## Non-Clinical Testing

### Biocompatibility Testing

The Full Length 046 Access System is constructed using materials that are commonly used in the medical device industry. All patient contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1 “Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.”

The Full Length 046 Access System is classified per ISO 10993-1 as an externally communicating device directly contacting circulating blood for a limited duration (≤ 24 hours). A summary of the biocompatibility testing conducted on the Full Length 046 Access System is provided below.

| Test | Method | Result |
| --- | --- | --- |
| Cytotoxicity | ISO MEM Elution with L-929 Cells | The test article met the requirements of the test. |
| Sensitization | ISO Guinea Pig Maximization Sensitization Test (Sodium Chloride USP Solution and Sesame Oil) | The test article was not considered a sensitizer. |
| Irritation | ISO Intracutaneous Reactivity (Sodium Chloride USP Solution and Sesame Oil) | Requirements of the ISO intracutaneous reactivity test were met for the test article. |
| Acute Systemic Toxicity | ISO Acute Systemic Injection (Sodium Chloride USP Solution and Sesame Oil) | Requirements of the ISO acute systemic injection test were met for the test article. |
| Material Mediated Pyrogenicity | USP Rabbit Pyrogen Study, Material Mediated (Sterile Non-Pyrogenic Saline) | The test article met the requirements for the absence of pyrogens. |
| Hemocompatibility - Hemolysis | ASTM F756 Hemolysis (Direct and Indirect (Extract)) | The test article is considered non-hemolytic. |
| Hemocompatibility - Partial Thromboplastin Time Assay | ASTM F2382 Partial Thromboplastin Time | The test article met the requirements of the test. |
| Hemocompatibility - Complement Activation Assay | SC5b-9 Complement Activation Assay | The concentration of SC5b-9 in the test article was lower than the concentration in the control article. The test article would not be expected to result in adverse effects in vivo. |
| Hemocompatibility - Platelet/Leukocyte Count | Platelet/Leukocyte Count Assay (ISO); ASTM F2888 | The test article met the requirements of the test. |
| Comparative Assessment of Geometry and Surface Characteristics | Comparative geometry and surface assessment using 40X magnification. | The subject device is comparable to the predicate device in terms of both macrogeometry and surface features. |

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# Performance Testing

The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Full Length 046 Access System is suitable for its intended use.

| Test | Test Method | Results |
| --- | --- | --- |
| Dimensional Verification | Device dimensions were measured to confirm conformance to the specifications. | **PASS** All samples met the pre-determined acceptance criteria. |
| Luer Integrity | Tested per ISO 80369-7. | **PASS** All samples met the pre-determined acceptance criteria. |
| Tensile Strength | The tensile strength of the catheter sections and bonds was tested. | **PASS** All samples met the pre-determined acceptance criteria. |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | **PASS** All samples met the pre-determined acceptance criteria. |
| Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation. | **PASS** All samples met the pre-determined acceptance criteria. |
| Tip Flexibility | Test specimens were tested for tip flexibility. | **PASS** All samples met the pre-determined acceptance criteria. |
| Air Leakage | Tested per ISO 10555-1, Annex D. | **PASS** All samples met the pre-determined acceptance criteria. |
| Liquid Leakage | Tested per ISO 10555-1, Annex C. | **PASS** All samples met the pre-determined acceptance criteria. |
| Static Burst | Tested per ISO 10555-1, Annex F. | **PASS** All samples met the pre-determined acceptance criteria. |
| Dynamic Burst | Mechanical integrity was maintained up to the specified pressures. | **PASS** All samples met the pre-determined acceptance criteria. |

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| Test | Test Method | Results |
| --- | --- | --- |
| Particulate Testing | The size and quantity of particulate matter generated during simulated use testing were determined. | **PASS** All samples met the pre-determined acceptance criteria. |
| Simulated Use Testing | Deliverability and compatibility with accessory devices were evaluated in a neurovascular model. | **PASS** All samples met the pre-determined acceptance criteria. |
| Delivery / Retrieval Force Testing | The forces to deliver and retrieve the subject device in an anatomical model were measured. | **PASS** |
| Radiopacity | The visibility of the radiopaque markers was evaluated under fluoroscopy and compared to the predicate. | **PASS** |

### Sterilization

The Route 92 Medical Full Length 046 Access System is sterilized by ethylene oxide to sterility assurance level of 10⁻⁶. The device has been adopted into an existing validated cycle per AAMI TIR28:2016.

### Conclusions

The Route 92 Medical Full Length 046 Access System has the same intended use, similar technological characteristics, and the same method of action as the predicate device. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness of the device. The successful completion of performance testing demonstrates that the Route 92 Medical Full Length 046 Access System is substantially equivalent to the predicate device.

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