CROSSLEAD Standard 035 and CROSSLEAD Stiff 035

K261281 · Filmecc Co., Ltd. · DQX · Sep 3, 2026 · Cardiovascular

Device Facts

• Record ID: K261281
• Device Name: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
• Applicant: Filmecc Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 3, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Indications for Use

This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is intended for peripheral vascular use only.

Device Story

Steerable peripheral guidewire; Ni-Ti alloy tapered core wire; hydrophilic coating; used to direct catheters in peripheral vasculature; operated by clinicians during diagnostic/interventional procedures; provides mechanical guidance for catheter placement; benefits patient by facilitating access to target anatomical sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing following FDA guidance for peripheral guidewires. Tests included tensile strength, torque strength, torqueability, tip flexibility, coating adhesion, catheter compatibility, dimensional verification, kink resistance, and radiopacity. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, reactivity, pyrogenicity, systemic toxicity, hemolysis, PTT, platelet-leukocyte, and complement activation).

Technological Characteristics

Ni-Ti alloy tapered core wire; hydrophilic coating; polyurethane/tungsten distal coating; 0.035-inch diameter; lengths 1500-3000mm; sterile (Ethylene Oxide, SAL 10^-6); non-coil design; biocompatibility per ISO 10993; performance testing per FDA guidance for peripheral guidewires.

Indications for Use

Indicated for directing catheters to desired anatomical locations in the peripheral vasculature during diagnostic or interventional procedures.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• CROSSLEAD Peripheral Guide Wire (K213315)

Reference Devices

• Terumo Radifocus Guidewire (K863138/K152740)
• VASSALLO GT Crossing 14 (K232574)

Submission Summary (Full Text)

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

September 3, 2026

Filmecc Co., Ltd.
% Meagan Fagan
Principal Consultant
Cardiomed Device Consultants
3618 Braverton St.
Edgewater, Maryland 21037

Re: K261281

Trade/Device Name: CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 Peripheral Guide Wire
Regulation Number: 21 CFR 870.1330
Regulation Name: Catheter Guide Wire
Regulatory Class: Class II
Product Code: DQX
Dated: August 4, 2026
Received: August 4, 2026

Dear Meagan Fagan:

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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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,

JENNY R.

KATSNELSON -S

Digitally signed by JENNY R. KATSNELSON -S

Date: 2026.09.03 23:16:49 -04'00'

for Lydia Glaw

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

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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: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K261281

Device Name
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 Peripheral Guide Wire

Indications for Use (Describe)

This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is intended for peripheral vascular use only.

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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FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services [phone] EF

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## 510(k) Summary [as required per 21 CFR 807.92]

510(k) K261281

| **Date Prepared** | April 17, 2026 |
| --- | --- |
| **Applicant:** | Filmecc Co., Ltd. 3-99 Akatsuki-cho Seto-shi, Aichi 489-0071 Japan TEL: [phone]; FAX: [phone] |
| **Contact Person:** | Meagan Fagan CardioMed Device Consultants, LLC 3168 Braverton Street Edgewater, Maryland 21037 [phone] [e-mail] |
| **Trade Name:** | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 Peripheral Guide Wire |
| **Common Name:** | Peripheral Guide Wire |
| **Device Classification:** | Class II per 21 CFR 870.1330 |
| **Classification Name:** | Catheter, Guide, Wire |
| **Product Code:** | DQX – Catheter Guide Wire |
| **Predicate Device:** | CROSSLEAD Peripheral Guide Wire (K213315) |
| **Reference Devices:** | Terumo Radifocus Guidewire (K863138/K152740) VASSALLO GT Crossing 14 (K232574) |

### Indication For Use/Intended Use:

*This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is intended for peripheral vascular use only.*

### Description:

The CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 are steerable guidewires designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. The guidewires have a maximum diameter of 0.035 inches

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(0.89mm) and are available in lengths of 1500mm, 1800mm, 2600mm and 3000mm. The guide wire is constructed from a Ni-Ti alloy tapered core wire. A hydrophilic coating is applied to the full length of the guidewire. An underlying urethane coating is applied to the distal portion of the guide wire.

### Comparison with Predicate Device

A side-by-side comparison of key characteristics and a discussion of the similarities/differences between the subject device and the predicate devices is provided below.

A claim of substantial equivalence is supported by the following:

- The same indication for use and intended use
- The same operating principle
- The same/similar basic design feature
- Same/similar materials of construction

Comparison of the subject device and the predicate devices show that the technological characteristics, such as components, design, sterilization method, and operating principle are similar and/or identical to the currently marketed predicate device

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**Table 1. Comparison of Subject and Predicate Devices**

| Device Name | Subject Devices | | Predicate Device | Reference Devices | | Comparison |
| --- | --- | --- | --- | --- | --- | --- |
| | CROSSLEAD Standard 035 | CROSSLEAD Stiff 035 | CROSSLEAD Peripheral Guide Wire | Terumo Radifocus Guide Wire | VASSALLO GT 14 Crossing | |
| **Applicant** | Filmecc Co., Ltd. | | ASAHI INTECC CO., LTD. | TERUMO Co., Ltd. | Filmecc Co., Ltd. | |
| **510(k) Number** | Current Application | Current Application | K213315 | K863138/K152740 | K232574 | |
| **Indication for Use** | This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is intended for peripheral vascular use only | This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is intended for peripheral vascular use only | This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures | The Glidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures. | This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only | Same as Predicate Device |
| **Overall length** | 1500mm, 1800 mm, 2600 mm, 3000mm | 1500mm, 1800 mm, 2600 mm, 3000mm | 2000mm,3000mm | 300-3000mm | 1900mm, 3000mm | Similar to Predicate and Reference Devices |
| **Tip shape** | Straight Angled (45°) | Straight Angled (45°) | Straight Angled (65°) | Straight Angled (45°) | Straight | Same as Predicate and Reference device |
| **Outer OD** | 0.89mm (0.035') No Coil | 0.89mm (0.035') No Coil | 0.89mm (0.035') | 0.45mm-1.32mm (0.018'-0.052') No Coil | 0.36mm (0.014') | Same as Predicate Device |
| **Outer Coil** | No | No | Yes - SUS | No | Yes – Platinum-Nickel | Same as Reference device |
| **Inner Coil** | No | No | Yes - SUS | No | No | Same as Reference devices |
| **Tapered Core Wire** | Nickel-Titanium alloy | Nickel-Titanium alloy | Nickel-Titanium alloy | Nickel-Titanium alloy | Stainless Steel | Same as Predicate and Reference device |
| **Under Coating (non blood contact)** | Silane | Silane | Nitrocellulose Polycarbonate Urethane | Unknown | N/A | Determine equivalence by conducting a biological evaluation using the final product. |

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| Device Name | Subject Devices | | Predicate Device | Reference Devices | | Comparison |
| --- | --- | --- | --- | --- | --- | --- |
| | CROSSLEAD Standard 035 | CROSSLEAD Stiff 035 | CROSSLEAD Peripheral Guide Wire | Terumo Radifocus Guide Wire | VASSALLO GT 14 Crossing | |
| **First Coating** | Polyurethane containing Tungsten (Tungsten/ Polyurethane) | Polyurethane containing Tungsten (Tungsten/ Polyurethane) | Polyurethane elastomer | Polyurethane containing Tungsten (Tungsten/ Polyurethane) | Polytetrafluoroethylene (PTFE) | Same as Reference Device |
| **Second Coating** | Polyvinyl pyrrolidone Nitrocellulose Polycarbonate Urethane | Polyvinyl pyrrolidone Nitrocellulose Polycarbonate Urethane | <Distal>Hydrophilic <Proximal> Hydrophobic | Hydrophilic polymer (Half-ester methyl vinyl ether-maleic anhydride copolymer) | Polyvinyl pyrrolidone Nitrocellulose Polycarbonate Urethane | Same as Reference Device |
| **Packaging Configuration** | Wire in holder tube, sealed in bag | Wire in holder tube, sealed in bag | Wire in holder tube, sealed in bag | Individual package Unit box Shipping carton | Wire in holder tube, sealed in bag | Same as Predicate and Reference device |
| **Accessories** | — | — | Shaping needle | Guide wire inserter | Torque device | Subject has no accessories |
| **Use with Optional Extension Wire** | — | — | Yes, 190cm length device | — | Yes, 190cm length device | Subject is not used with extension wires connected |
| **Sterilization** | Provided sterile via Ethylene Oxide to SAL 10^{-6} | Provided sterile via Ethylene Oxide to SAL 10^{-6} | Provided sterile via Ethylene Oxide to SAL 10^{-6} | Provided sterile via Ethylene Oxide to SAL 10^{-6} | Provided sterile via Ethylene Oxide to SAL 10^{-6} | Same as Predicate and Reference devices |
| **Shelf Life** | 0.5 years | 0.5 years | 3 years | 24 months | 3 years | Different; testing to be performed to support future extension of shelf life |

### Non-Clinical Testing/Performance Data

The substantial equivalence of the CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 was evaluated in bench testing that followed the recommendations outlined in FDA's Guidance Document, "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling, published October 10, 2019.

- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Adhesion/Integrity
- Catheter Compatibility
- Dimensional Verification
- Kink Resistance
- Visual Inspection
- Corrosion
- Radiopacity

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The in vitro bench tests demonstrated that the CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the subject device functions as intended and that it is similar to the predicate device.

## Biocompatibility

The CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 were tested in accordance with ISO 10993 and found to be biocompatibility. The test performed are summarized in the table below.

**Table 2. Biocompatibility Summary Table**

| Endpoint/Test Method/Relevant Standard | Acceptance Criteria | Test Result |
| --- | --- | --- |
| Cytotoxicity; MEM Elution ISO 10993-5 | Biological response <2 (mild) | Pass |
| Sensitization; Kligman Maximization ISO 10993-10 | Overall pattern, intensity, duration, character of reactions compared to control conditions | Pass |
| Intracutaneous Reactivity; Intracutaneous Injection in Rabbit ISO 10993-23 | Difference between test extract mean score and corresponding control mean score ≤ 1 | Pass |
| Material Mediated Pyrogenicity; Rabbit Injection ISO 10993-11 | No single animal shows a body temperature rise of ≥ 0.5°C | Pass |
| Acute Systemic Toxicity; Mouse Injection ISO 10993-11 | None of the animals treated with the test article show a significantly greater biological reactivity than the animals treated with the control device | Pass |
| Hemolysis (Indirect and Direct Contact) ISO 10993-4, ASTM F756 | ≤ 2 % hemolytic | Pass |
| Partial Thromboplastin Time (PTT Measurement) ISO 10993-4, ASTM F2382 | Test article does not have a statistically lower clotting time when compared to the negative control | Pass |
| Platelet-Leukocyte Testing (PLC) ISO 10993-4, ASTM F2888 | Test article platelet mean percentage value is 80 to 120% of the vehicle control and the test article platelet mean percentage value is at least 30% above the positive control | Pass |
| Complement Activation SC5b-9; blood ISO 10993-4 | Comparison to the negative controls | Pass |

## Conclusion

The subject device has the same indication for use/intended use as compared to the predicate device, in addition to having similar technological characteristics and incorporating similar materials of construction as the predicate device. The subject device is comparable to the predicate based on the indication for use, materials, technology, performance and/or design.

The results from the non-clinical testing performed confirm that the subject device performs as intended, in alignment with its indication for use. Any differences between the subject and predicate device do not raise new questions compared to the predicate. These results, along with the comparison of technological characteristics, demonstrate that the subject device is substantially equivalent to the predicate device.