(220 days)
The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature.
The SurfRider 13 Microcatheter is a single-lumen microcatheter with a gradual stiffness change from tip to proximal end, reinforced with a metal braid to facilitate delivery to distal vessels and to serve as a delivery path of contrast media, embolic agents and coils. The distal end has two radiopaque markers to facilitate fluoroscopic visualization, and two types of tips: a straight tip and a pre-shaped tip. The proximal end of the Microcatheter incorporates a standard luer adaptor to facilitate the attachment of accessories. The outer surface of the Microcatheter has a hydrophilic coating to increase lubricity. The Microcatheter is designed to be introduced over a steerable guidewire into the vasculature.
N/A
FDA 510(k) Clearance Letter - SurfRider 13 Microcatheter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
January 5, 2026
Kaneka Americas Holding, Inc.
℅ Darci Diage
Quality and Regulatory Consultant
MedEdge
635 Hibiscus Street, #2101
West Palm, Florida 33401
Re: K251668
Trade/Device Name: SurfRider 13 Microcatheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP, KRA
Dated: December 4, 2025
Received: December 4, 2025
Dear Darci Diage:
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.
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K251668 - Darci Diage 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 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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K251668 - Darci Diage Page 3
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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FORM FDA 3881 (8/23) Page 1 of 1
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): K251668
Device Name: SurfRider 13 Microcatheter
Indications for Use (Describe):
The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into 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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K251668
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510(k) Summary
Date of preparation: December 30, 2025
Submitter: Kaneka Americas Holding, Inc.
7979 Gateway Blvd., Suite 220
Newark, CA 94560
Contact Person: Darci Diage
MedEdge
635 Hibiscus St, #2101
West Palm, FL 33401
Phone: (707) 953-2615
e-mail: darci@tpconsulting.net
Trade Name: SurfRider 13 Microcatheter
Common Name: Percutaneous catheter
Classification: Class II
Product Code: QJP, KRA
Regulation: 870.1250 (Percutaneous Catheter), 870.1210 (Continuous Flush Catheter)
Predicate Device(s): Phenom™ Catheters K210230
Reference Device(s): Marathon™ Flow Directed Micro Catheter K202318
Device Description: The SurfRider 13 Microcatheter is a single-lumen microcatheter with a gradual stiffness change from tip to proximal end, reinforced with a metal braid to facilitate delivery to distal vessels and to serve as a delivery path of contrast media, embolic agents and coils. The distal end has two radiopaque markers to facilitate fluoroscopic visualization, and two types of tips: a straight tip and a pre-shaped tip. The proximal end of the Microcatheter incorporates a standard luer adaptor to facilitate the attachment of accessories. The outer surface of the Microcatheter has a hydrophilic coating to increase lubricity. The Microcatheter is designed to be introduced over a steerable guidewire into the vasculature.
Indication for Use: The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature.
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Comparison of technological characteristics with the predicate
The subject device has the same principle of operation and similar technological characteristics as the predicate device Phenom™ Catheters (K210230 cleared on February 25, 2021) and the reference device Marathon™ Flow Directed Micro Catheter (K202318 cleared on September 14, 2020).
A tabular comparison of the intended use and technological characteristics between the subject, predicate and reference devices is provided below:
| SurfRider 13 Microcatheter (Subject Device) | Phenom™ Catheters (Predicate Device) | Marathon™ Flow Directed Micro Catheter (Reference Device) | |
|---|---|---|---|
| 510(k) Number | K251668 | K210230 | K202318 |
| Manufacturer | Kaneka Americas Holding, Inc. | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Classification | Class II | Class II | Class II |
| Product Code(s) | QJP, KRA | DQY, QJP, KRA | KRA, QJP |
| Regulation | 870.1250, 870.1210 | 870.1250, 870.1210 | 870.1210, 870.1250 |
| Medical Specialty | Cardiovascular | Cardiovascular | Cardiovascular |
| Indications for Use | The SurfRider 13 Microcatheter is intended for the introduction of interventional devices, such as embolic coils, or diagnostic agents into the neurovasculature. | Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures. | The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media. |
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| SurfRider 13 Microcatheter (Subject Device) | Phenom™ Catheters (Predicate Device) | Marathon™ Flow Directed Micro Catheter (Reference Device) | |
|---|---|---|---|
| Proximal/Distal Outer Diameter (OD) | Proximal: 0.037", Distal: 0.022" | Proximal: 0.029"-0.061", Distal: 0.024" – 0.055" | Proximal: 0.040", Distal: 0.020" |
| Distal Inner Diameter (ID) at Tip | 0.013" | 0.017"-0.0445" | 0.013" |
| Min. Guiding Catheter ID | ≥ 0.070" | ≥ 0.035" – 0.070" | ≥ 0.053" |
| Max. Guidewire OD | ≤ 0.010" | ≤ 0.014" – 0.041" | ≤ 0.010" |
| Effective Length | 165 cm | 75-170 cm | 165 cm |
| Distal Segment Length | 5 cm | 6 – 20 cm | 25 cm |
| No. of Lumens | Single lumen | Single lumen | Single lumen |
| Shaft | Progressively softer from proximal end to distal tip | Progressively softer from proximal end to distal tip | Semi-rigid proximal shaft and a highly flexible distal shaft |
| Shaft Materials | PTFE and Pebax | PTFE and Pebax | PTFE, Grilamid and Pebax |
| Shaft Reinforcement | Metallic (Stainless Steel) reinforced | Metallic (Stainless Steel) reinforced | Stainless Steel helical coil |
| Inner Liner | PTFE liner | PTFE liner | PTFE liner |
| Marker Band | Platinum-Iridium Alloy | Radiopaque marker band | Platinum-Iridium Alloy |
| Tip Markers | 2 | 1-2 | 1 |
| Tip Shaping | Pre-shaped and steam shapeable straight tips | Pre-shaped and steam shapeable straight tips | Steam shapeable straight tip |
| Coating | Hydrophilic coating | Hydrophilic coating | Proprietary Hyaluronic acid, acrylic resin binder |
| Shaping Mandrel | Yes | Yes | Yes |
| Introducer Sheath | Yes | Yes | No |
| Sterilization Method | Ethylene Oxide (EO) | EO | EO |
| Minimum SAL | SAL 10⁻⁶ | SAL 10⁻⁶ | SAL 10⁻⁶ |
| Method of Supply | Sterile, Single Use | Sterile, Single Use | Sterile, Single Use |
| Biocompatibility | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 | Biocompatible per ISO 10993-1 |
| Shelf-Life | 36 months | 12 months | 12 months |
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Performance bench testing
Non-clinical bench testing was performed to evaluate the SurfRider 13 Microcatheter and to support substantial equivalence. The following testing/assessments were performed:
| Test | Test method summary | Results/conclusion |
|---|---|---|
| Visual appearance | Catheter surface was checked for cleanliness and absence of defects. | All samples met the acceptance criteria. |
| Dimensions | Catheter dimensions were measured to confirm they meet design specifications. | All samples met the acceptance criteria. |
| Radiopacity | The catheter was evaluated for visibility under X-ray imaging. | All samples met the acceptance criteria. |
| Simulated use | The catheter was used in a simulated anatomical model to assess overall performance and compatibility with ancillary devices. | All samples met the acceptance criteria. |
| Compatibility with liquid embolic materials | Compatibility with liquid embolic materials was evaluated. | All samples met the acceptance criteria. |
| Flow rate | Flow rate through the catheter was measured. | All samples met the acceptance criteria. |
| Liquid leakage | The catheter was pressurized with liquid and checked for leaks. | All samples met the acceptance criteria. |
| Air leakage | Vacuum was applied and the hub was examined for leaks. | All samples met the acceptance criteria. |
| Static burst pressure | The catheter was pressurized until failure to assess burst pressure. | All samples met the acceptance criteria. |
| Peak tensile force | Tensile force was applied to every joint to assess mechanical strength. | All samples met the acceptance criteria. |
| Tip stiffness | Flexibility of the catheter tip was measured. | All samples met the acceptance criteria. |
| Steam shape retention | Shape retention after steam shaping was measured. | All samples met the acceptance criteria. |
| Kink resistance | The catheter was wrapped around mandrels of various sizes to assess resistance to kinking. | All samples met the acceptance criteria. |
| Torque resistance | The catheter was rotated in a simulated anatomical model to assess resistance to torsional stress. | All samples met the acceptance criteria. |
| Dynamic burst pressure | Dynamic resistance to liquid injection pressure was measured. | All samples met the acceptance criteria. |
| Corrosion resistance | Evaluated per ISO 10555-1. | All samples met the acceptance criteria. |
| Coil deliverability | Performance during delivery of embolization coils through the catheter was assessed in a simulated anatomical model. | All samples met the acceptance criteria. |
| Stability while coiling | Catheter stability during coil embolization was assessed in a simulated anatomical model. | All samples met the acceptance criteria. |
| Coil delivery force | Coil delivery force was measured in a simulated anatomical model. | All samples met the acceptance criteria. |
| Hub | The hub was tested for dimensions, leakage, mechanical integrity and compatibility. | All samples met the acceptance criteria. |
| Coating integrity/particulate | The catheter was tracked in a simulated anatomical model to assess coating integrity and particulate release. | All samples met the acceptance criteria. |
| Coating lubricity | Pinch friction forces were measured. | All samples met the acceptance criteria. |
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Non-clinical bench testing demonstrated that the SurfRider 13 Microcatheter met all pre-established acceptance criteria, functions as intended, and performs similar to the predicate device and the reference device.
Biocompatibility
The biocompatibility evaluation for the SurfRider 13 Microcatheter was conducted in accordance with the FDA guidance, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process"," and International Standard ISO 10993 series. Per ISO 10993-1, the SurfRider 13 Microcatheter was categorized as an externally communicating device with circulating blood contact for a limited duration of contact (≤ 24 hours). The biocompatibility testing included the following tests:
| Test | Test summary | Conclusion |
|---|---|---|
| Acute systemic toxicity Systemic injection ISO 10993-11 | Determine the potential toxic effects of the test article extract resulting from a single-dose systemic injection of polar and non-polar extracts in mice. | Non-toxic |
| Cytotoxicity MEM elution method ISO 10993-5 | Determine the potential cytotoxicity of a mammalian cell culture (L929) in response to the test article extract. | Non-cytotoxic |
| Intracutaneous irritation Intracutaneous injection ISO 10993-23 | Determine the potential irritation effect of the test article extract resulting from intracutaneous injection of polar and non-polar extracts in rabbits. | Non-irritant |
| Material mediated pyrogenicity Rabbit pyrogen study ISO 10993-11 | Determine the potential presence of material-mediated pyrogen. | Non-pyrogenic |
| Sensitization Maximization test ISO 10993-10 | Determine the potential delayed dermal contact sensitization effect of the test article extract resulting from repeated injection of polar and non-polar extracts in guinea pig. | Non-sensitizing |
| Hemocompatibility Hemolysis (extract and direct contact) ISO 10993-4 | Determine the potential hemolytic effect of the test article resulting from direct and indirect (extract) contact. | Non-hemolytic |
| Hemocompatibility Complement activation (SC5b-9) ISO 10993-4 | Determine the potential activation of the SC5b-9 complement system for the test article and the comparison article. | Non-activator |
| Hemocompatibility Partial thromboplastin time assay ISO 10993-4 | Determine the potential activation of the human blood coagulation pathway for the test article and the comparison article. | Non-activator |
| Hemocompatibility Platelet and leukocyte counts ISO 10993-4 | Determine the potential effect for platelet and leukocyte ratios in human whole blood for the test article and the comparison article. | No effect |
| Hemocompatibility In vitro blood loop assay ISO 10993-4 | Determine the thrombogenicity of sheep whole blood for the test article and the comparison article. | Thromboresistant |
In addition to the performance testing and biocompatibility testing, compatibility with liquid embolic materials was further assessed using a paper-based risk assessment.
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Sterility
The SurfRider 13 Microcatheter sterilization process using ethylene oxide (EO) has been validated in accordance with ISO 11135-1:2014 to achieve a sterility assurance level (SAL) of 10⁻⁶. EO and ethylene chlorohydrin (ECH) residuals were below limits specified in ISO 10993-7:2008. Bacterial endotoxin levels were below the level of 2.15 endotoxin units (EU)/device.
Shelf-life
Both baseline and accelerated shelf-life testing were conducted. The results demonstrated that the SurfRider 13 Microcatheter has three-year shelf life.
Animal testing
No animal testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Clinical testing
No clinical testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Conclusions
The SurfRider 13 Microcatheter's intended use, indications for use, materials, and fundamental scientific technology are similar to the predicate device. The differences between the subject device and the predicate device do not raise new questions of safety and effectiveness. Bench, biocompatibility, and shelf-life testing demonstrate that the subject device performs as intended and is substantially equivalent to the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).