PATH BGC

K260938 · Crossroads Neurovascular, Inc. · QJP · Apr 15, 2026 · Cardiovascular

Device Facts

• Record ID: K260938
• Device Name: PATH BGC
• Applicant: Crossroads Neurovascular, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Apr 15, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Indications for Use

PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

Device Story

PATH BGC is a dual coaxial lumen balloon guide catheter; inner coil-reinforced and outer braid-reinforced variable stiffness lumens. Features compliant balloon near distal end for temporary vascular occlusion; radiopaque markers at tip and balloon ends; hydrophilic coating on distal/proximal ends; bifurcated luer hub for flushing/inflation. Used in neurovascular angiographic procedures; operated by physicians in clinical settings. Device facilitates insertion/guidance of intravascular catheters; balloon provides temporary occlusion to assist in procedures. Output is mechanical vascular access and occlusion; provider uses fluoroscopic visualization to guide device and monitor balloon inflation. Benefits include improved access and procedural control during neurovascular interventions.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench performance testing, including dimensional inspection, kink resistance, coating lubricity, radiopacity, delivery/retrieval forces, balloon deflation/fatigue/burst, and mechanical integrity (tensile, torque, leak). Particulate testing met acceptance criteria.

Technological Characteristics

Dual coaxial lumen catheter; inner/outer jackets: Pebax; distal tip/balloon: polyurethane; braid: stainless steel; marker band: platinum/iridium; hub: polycarbonate. Sterilization: Ethylene oxide (EtO). Standards: ISO 10555-1 (mechanical/leak/burst), ISO 80369-7 (luer compatibility), ASTM F2096-11 (packaging), ASTM F88 (seal strength).

Indications for Use

Indicated for patients requiring intravascular catheter guidance and temporary vascular occlusion during neurovascular angiographic procedures.

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

• PATH BGC Balloon Guide Catheter (K242392)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 15, 2026

Crossroads Neurovascular, Inc.
Ryan Breckenridge
QA/RA Consultant
105 North Pointe Drive, Suite D
Lake Forest, CA 92630

Re: K260938
Trade/Device Name: PATH BGC
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP
Dated: March 20, 2026
Received: March 20, 2026

Dear Ryan Breckenridge:

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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K260938 - Ryan Breckenridge
Page 2

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.

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K260938 - Ryan Breckenridge
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See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,

**JAIME RABEN -S**

for Naira Muradyan
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) K260938 | |
| Device Name PATH BGC | |
| Indications for Use (Describe) PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures. | |
| 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 – K260938

As required by 21 CFR 807.92

I. SUBMITTER

| Applicant: | Crossroads Neurovascular, Inc.
105 North Pointe Drive, Suite D
Lake Forest, CA 92630 |
| --- | --- |
| Contact: | Ryan Breckenridge
Telephone: [phone]
Email: [e-mail] |
| Date Prepared: | April 14, 2026 |

II. DEVICE

| Device Trade Name: | PATH BGC |
| --- | --- |
| Device Common Name: | Balloon Guide Catheter |
| Classification Name: | Catheter, Percutaneous |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | QJP |

III. PREDICATE DEVICE

| Predicate Device: | PATH BGC Balloon Guide Catheter, K242392 |
| --- | --- |

IV. DEVICE DESCRIPTION

The PATH Balloon Guide Catheter (PATH BGC) is a dual coaxial lumen catheter consisting of an inner coil reinforced variable stiffness lumen and an outer braid reinforced variable stiffness lumen. A radiopaque marker is included at the tip of the catheter and at the distal and proximal ends of the balloon. A compliant balloon is mounted near the distal end of the catheter to provide vascular occlusion during angiographic procedures. The catheter has hydrophilic coating at the distal and proximal end. A bifurcated luer hub on the proximal end allows attachments for flushing and balloon inflation.

V. INDICATIONS FOR USE

PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below provides the comparison of technological characteristics and indications for use of the subject device with the predicate device.

Table 1: Comparison of Predicate and Subject Devices

| Feature | Predicate Device PATH BGC | Subject Device PATH BGC |
| --- | --- | --- |
| | K242392 | K260938 |
| Indications for Use | PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures. | Same |
| Device Description | The PATH BGC is a dual coaxial lumen catheter consisting of an inner coil reinforced variable stiffness lumen and an outer braid reinforced variable stiffness lumen. A radiopaque marker is included at the tip of the catheter and at the distal and proximal ends of the balloon. A compliant balloon is mounted near the distal end of the catheter to provide vascular occlusion during angiographic procedures. The catheter has hydrophilic coating at the distal and proximal end. A bifurcated luer hub on the proximal end allows attachments for flushing and balloon inflation. | Same |
| Outer Jacket | Neusoft UR862A Pebax | Same |
| Inner Jacket | Neusoft UR862A Pebax | Same |
| Distal Tip | Polyurethane | Same |
| Balloon Material | Polyurethane | Same |
| Braid | Stainless Steel | Same |
| Braid Distal End Securement | Cyanoacrylate | Same |
| Marker Band | Platinum/Iridium | Same |
| Catheter Hub | Polycarbonate | Same |
| Strain Relief | Polyurethane | Same |

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| Feature | Predicate Device
PATH BGC | Subject Device
PATH BGC |
| --- | --- | --- |
| | K242392 | K260938 |
| Labeled Shaft Inner/Outer Diameter (Nominal) | Inner Diameter:
0.070in

Outer Diameter:
0.0965in | Same |
| Maximum Outer Diameter Along Effective Length | 0.0965in | Same |
| Effective Lengths | 90cm, 95cm, 100cm, and 105cm | Same |
| Distal Tip Length | 2cm | Same |
| Radiopaque Marker Length (Nominal) | 0.035in | Same |
| Accessory Devices Provided | Peel Away Sheath
Rotating Hemostatic Valve with Sideport
Luer Activated Valve | Same |
| Packaging Materials & Configuration | Polyethylene Tube and HDPE Packaging Card
Tyvek/LLDPE Pouch | Same |
| Sterilization Method | Ethylene oxide (EtO) | Same |
| How Supplied | Sterile, Single Use | Same |

## VII. PERFORMANCE DATA

To establish substantial equivalence of the subject device and ensure the device meets the design specifications and requirements, non-clinical bench performance testing was conducted per the risk analysis. The testing performed and results are summarized below.

### Design Verification Testing – Bench

Performance testing was conducted to support the PATH BGC submission. The results of the design verification and validation testing (Table 2) confirm that the subject device conforms to the pre-defined specifications and test acceptance criteria are met.

Table 2: PATH BGC Bench Testing Summary

| Test | Description | Results |
| --- | --- | --- |
| Visual Inspection | To verify the visual surface requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Dimensional Inspection | To verify the dimensional specifications are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Simulated Use | To evaluate the performance of the device and accessories in simulated anatomy model. | This characteristic is unchanged and relies on the |

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| | | successful testing from the predicate K242392. |
| --- | --- | --- |
| Kink Resistance | To evaluate the device around bends of clinically relevant radii and verify kink resistance requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Coating Lubricity | To evaluate frictional forces and verify coating lubricity requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Radiopacity | To evaluate marker band visibility under fluoroscopy. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Delivery/Retrieval | To evaluate the device in an anatomical model and determine the maximum forces required to completely deliver and retrieve the PATH BGC. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Balloon Deflation Time | To verify balloon deflation time requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Distal Tip Stiffness | To evaluate distal tip deflection force and verify distal tip stiffness requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Coating Integrity | To evaluate device pre- and post-insertion and retrieval through a simulated vascular model and verify coating integrity requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Torque Strength | To evaluate device integrity after applied hub rotations with distal end held stationary and verify torque strength requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Shaft & Hub Tensile | To verify tensile strength requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Liquid Leak | To verify liquid leak requirements per ISO 10555-1 are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Air Leak | To verify air leak requirements per ISO 10555-1 are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Hub Compatibility | To verify BGC bifurcated luer hub requirements per ISO 80369-7 are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| RHV Luer | To verify RHV luer requirements per ISO 80369-7 are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |

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| Static Burst | To verify static burst requirements per ISO 10555-1 are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| --- | --- | --- |
| Dynamic Burst | To verify dynamic burst requirements per ISO 10555-1 are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Resistance to Lumen Collapse | To demonstrate that the main lumen does not collapse under aspiration. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Corrosion Resistance | To verify corrosion resistance requirements per ISO 10555-1 are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Particulate | To evaluate the device within a simulated anatomy model and verify particulate count is similar to the comparator device. | Pass – all samples met the pre-determined acceptance criteria. |
| Balloon Fatigue | To evaluate repetitive balloon inflation and deflation cycles and verify fatigue requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Balloon Burst Volume | To verify balloon burst volume requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Balloon Diameter to Inflation Volume (Compliance) | To characterize balloon diameter for pre-defined balloon inflation volumes. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Shelf Life | To verify device performance after accelerated aging. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Transit Testing | To subject the device, accessories, and packaging to environmental conditioning and shipping simulation and verify performance requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Packaging – Bubble Leak | To evaluate packaging per ASTM F2096-11 and verify requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Packaging – Pouch Seal Strength | To evaluate packaging per ASTM F88 Technique A (unsupported peel) and verify requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |
| Sterility | To subject the device, accessories, and packaging to sterilization and verify the requirements are met. | This characteristic is unchanged and relies on the successful testing from the predicate K242392. |

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Animal Study

An animal study was not deemed necessary to demonstrate substantial equivalence.

Sterilization and Shelf Life

Sterilization and shelf life testing was not deemed necessary to demonstrate substantial equivalence, since the change has no impact to device sterilization nor shelf life.

Biocompatibility

Biocompatibility testing was not deemed necessary to demonstrate substantial equivalence, since the change has no impact to device biocompatibility.

Clinical Study

A clinical study was not deemed necessary to demonstrate substantial equivalence.

VIII. CONCLUSIONS

The PATH BGC Balloon Guide Catheter and the predicate device, PATH BGC Balloon Guide Catheter, (K242392), have similar intended use, device operating principle, technological characteristics, and indications for use. The differences in technological characteristics do not raise new questions of safety or effectiveness. Successful completion of non-clinical bench performance testing demonstrates that the subject device meets the design specifications and functions as intended. Based on the information provided in this submission, the PATH BGC is substantially equivalent to the predicate, PATH BGC Balloon Guide Catheter, (K242392).