70 NeuGlide Catheter
Device Facts
| Record ID | K262277 |
|---|---|
| Device Name | 70 NeuGlide Catheter |
| Applicant | Piraeus Medical, Inc. |
| Product Code | QJP · Cardiovascular |
| Decision Date | Sep 4, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The 70 NeuGlide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Device Story
Single lumen guide catheter; provides access to peripheral, coronary, and neuro vasculature. Constructed of hollow cylindrical tube with metal coils/braids and medical grade polymers; features hydrophilic coating for tracking through tortuous vessels. Distal soft tip facilitates navigation; radiopaque marker allows visualization under fluoroscopy. Used by clinicians in interventional procedures; advanced over guidewires (0.035" or smaller) to target anatomy. Compatible with standard luer fittings, introducer sheaths, and rotating hemostasis valves. Facilitates delivery of interventional devices (e.g., support/diagnostic catheters). Benefits patient by enabling minimally invasive access to target vasculature for therapeutic or diagnostic interventions.
Clinical Evidence
Bench testing only. No clinical data. Performance verified via simulated use models, dimensional verification, mechanical testing (tensile, burst, torque, kink resistance), and biocompatibility adoption from predicate. All tests passed.
Technological Characteristics
Single lumen guide catheter; metal coils/braids with medical grade polymers. Hydrophilic coating. 5F compatible (0.070" ID). Radiopaque marker. Sterilized via Ethylene Oxide (ISO 11135, SAL 10^-6). Radiopacity tested per ASTM F640-23. Shelf life validated via accelerated aging (ASTM F1980).
Indications for Use
Indicated for introduction of interventional devices into peripheral, coronary, and neuro vasculature in adult patients.
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
- 87 NeuGlide Catheter (K240971)
Reference Devices
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
September 4, 2026
Piraeus Medical, Inc.
Sarah Kabanuk
COO
7351 Kirkwood Lane N, Suite 116
Maple Grove, Minnesota 55369
Re: K262277
Trade/Device Name: 70 NeuGlide Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP, DQY
Dated: August 5, 2026
Received: August 5, 2026
Dear Sarah Kabanuk:
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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K262277 - Sarah Kabanuk
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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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K262277 - Sarah Kabanuk
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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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# 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. | | K262277 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| 70 NeuGlide Catheter | | | |
| Please provide your Indications for Use below. | | | ? |
| The 70 NeuGlide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | | | |
| Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |
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K262277 Page 1 of 4
# 510(k) Summary, K262277
# A. Submitter Information
Submitter's Name:
Address:
Piraeus Medical, Inc.
7351 Kirkwood Lane N, Suite 116
Maple Grove, MN 55369
Contact Person:
Jared Hutar
Telephone:
320-630-2004
Email:
quality@piraeusmedical.com
Date of Preparation:
July 3, 2026
# B. Correspondent Information
Contact Name:
Sarah Kabanuk
Telephone:
320-630-2004
# C. Subject Device
Proprietary Names:
70 NeuGlide™ Catheter
Common/Usual Name:
Guide Catheter
Classification Name:
Catheter, Percutaneous, Neurovasculature
Product Code:
QJP, DQY
Regulation:
21 CFR 870.1250
# D. Predicate Device
Proprietary Name:
87 NeuGlide™ Catheter
Common/Usual Name:
Guide Catheter
Classification Name:
Catheter, Percutaneous, Neurovasculature
Product Code:
QJP, DQY
Regulation:
21 CFR. 870.1250
Manufacturer:
Piraeus Medical
510(k) #:
K240971
# E. Device Description
The Piraeus Medical 70 NeuGlide™ Catheter is a single lumen guide catheter that provides access to peripheral, coronary and neuro vasculature. 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 a combination of metal coils/braids and medical grade polymers. The catheter features a hydrophilic coating to enhance tracking through tortuous vasculature and facilitate the introduction of interventional devices to the peripheral, coronary and neurovasculature. The 70 NeuGlide™ guide catheter is compatible with 0.035" or smaller guidewires. The distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. The 70 NeuGlide™ Catheter has an inner diameter of 0.070" (5F compatible), and a maximum outer diameter of 0.084". The catheter is offered in working lengths of 95, 100 and 105 cm. The 70 NeuGlide™ guide catheter is packaged with a loading tool to aid in insertion of the catheter into a short sheath.
Accessory devices required, but not supplied include:
- Guidewires
- Support/diagnostic catheters
- Introducer sheaths
- Rotating Hemostasis valves (RHVs)
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K262277 Page 2 of 4
### F. Indications for Use
The 70 NeuGlide™ Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
### G. Principles of Operation
The 70 NeuGlide™ Catheter may be used with support catheters to assist in accessing the target vasculature. Use of the 70 NeuGlide™ Catheter relies on standard percutaneous interventional techniques, including access site preparation, introducing the catheter portion of the device, advancing the catheter under fluoroscopy, withdrawing the catheter, and closing the access site.
### H. Predicate Comparison
The predicate device is the 87 NeuGlide™ Catheter cleared under K240971. The predicate and subject devices share the same intended use and basic technological characteristics as shown in Table 1.
Table 1: Comparison of Predicate and Subject Devices
| Device Attribute | Predicate Device (K240971) | Subject Device (K262277) |
| --- | --- | --- |
| FDA Product Classification | Class II, QJP and DQY, 21 CFR 870.1250 | Same |
| Device Name | 87 NeuGlide™ Catheter | 70 NeuGlide™ Catheter |
| Indications for Use | The 87 NeuGlide™ Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature | The 70 NeuGlide™ Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Condition Supplied | Sterile and Single Use | Same |
| Sterilization Method | Ethylene Oxide (EO), SAL 10^{-6} | Same |
| Inner Diameter (Distal) | 0.087" | 0.070" |
| Outer Diameter (Distal) | 0.100" | 0.084" |
| Inner Diameter (Proximal) | 0.087" | 0.070" |
| Outer Diameter (Proximal) | 0.100" | 0.084" |
| Effective Length | 100 cm and 110 cm | 95 cm, 100 cm and 105 cm |
| Tip Design | Straight atraumatic tip | Same |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade plastics & metals with hydrophilic coating. | Same |
| Packaged Accessories | Loading Tool | Same |
| Packaging Configuration | The catheter is placed in a protective polyethylene tube, mounted with accessory loading tool onto a polyethylene packaging card, placed into a pouch, sealed and labeled. The sealed pouch and IFU are placed in a labeled shelf carton box. | Same |
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K262277 Page 3 of 4
# I. Performance Testing Supporting Substantial Equivalence
A summary of the supportive bench performance testing is presented in Table 2. These tests were performed per company approved protocols, test methods, and performance standards.
Table 2: Tests and Performance Specifications
| Test | Test Method Summary [standard and/or guidance] | Results |
| --- | --- | --- |
| Visual Inspection | The catheter was examined for surface defects or extraneous matter. The distal tip was inspected to confirm the presence of smooth, tapered or rounded edges. | Pass |
| Dimensional Verification | The catheter outer diameter, inner diameter, usable length, and coating length were measured. | Pass |
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be prepped, inserted, tracked, and retracted and removed per the Instructions for Use within a simulated use model without incurring any damage to the catheter. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. [FDA guidance PTA and Specialty Catheters] | Pass |
| Compatibility with Other Devices (External) | The catheter is compatible with 7F introducer (short) sheath. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Guidewire Compatibility | The catheter shall be able to be delivered over the maximum size guidewire indicated in the product labeling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Interventional Device Compatibility (Internal) | The catheter shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Luer Compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7 and ISO 80369-20. | Pass |
| Accessory Compatibility | Devices shall be compatible with accessories such as RHVs and the accessory loading tool. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient tensile bond strength in comparison to measured retrieval forces to remain intact throughout a procedure. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Freedom from Leakage – Positive Pressure | No liquid leakage from the hub or catheter shaft at 317 kPa (46 psi) for 30 seconds. [ISO 10555-1] | Pass |
| Freedom from Leakage – Negative Pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. [ISO 10555-1] | Pass |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) after wrapping around anatomically relevant bend radii. [FDA guidance PTA and Specialty Catheters] | Pass |
| Pushability | The proximal shaft of the catheter shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
| Access Force | Catheter shall not require excessive force to safely navigate and track to the target anatomy. [ISO 10555-1, FDA guidance PTA and Specialty Catheters] | Pass |
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K262277 Page 4 of 4
| Test | Test Method Summary [standard and/or guidance] | Results |
| --- | --- | --- |
| Static Burst | The distal tip of the catheter was blocked, and fluid was injected into the lumen at increasing pressure until the catheter burst per ISO 10555-1 and the static burst pressure was compared with the maximum pressure generated with manual syringe injection. | Pass |
| Torque Strength | The catheter was navigated through a clinically relevant tortuous path and with the distal tip secured the proximal end was rotated until failure. [FDA guidance PTA and Specialty Catheters] | Pass |
| Distal Tip Flexibility | Tip flexibility was measured with a force gauge to measure the compressive force exerted by the side of the catheter at a defined distance from the distal tip when the distal tip of the catheter is deflected. Results were compared to the predicate device and additional comparator neurovascular catheters with similar dimensions (K142321, K211990). | Pass |
| Particulate | The amount of particulate matter generated during simulated use testing was compared to the predicate. [FDA guidance PTA and Specialty Catheters] | Pass |
| Coating Lubricity, Durability, and Integrity | Durability and lubricity measured the frictional forces with a pinch test. The hydrophilic coating was examined for damage after simulated use. | Pass |
| Corrosion | Corrosion resistance evaluated the metallic components related to corrosion contacting the intended fluid path. [ISO 10555-1] | Pass |
| Radiopacity | Tested per ASTM F640-23. | Pass |
### J. Biocompatibility Testing
No new biocompatibility testing was conducted for the 70 NeuGlide™ Catheter. Biocompatibility assessments for the subject device were adopted from the predicate 87 NeuGlide™ Catheter.
### K. Sterilization
The 70 NeuGlide™ Catheter is sterilized using a validated EO process with a sterility assurance level of 1x10⁻⁶ validated per the overkill method in accordance with ISO 11135, “Sterilization of Health-Care Products - Ethylene Oxide - Requirements for The Development, Validation and Routine Control of a Sterilization Process For Medical Devices”.
### L. Shelf Life and Packaging
Accelerated aging testing based on ASTM F1980 was conducted to verify packaged device performance to support a 6-month shelf-life claim. Device and package performance were verified by functional and performance testing.
### M. Conclusions
The subject 70 NeuGlide™ Catheter and predicate 87 NeuGlide™ Catheter share the same intended use and basic technological characteristics. The differences in technological characteristics do not raise new or different questions of safety or effectiveness of the device. Based on the results of bench performance testing, the subject and predicate devices are substantially equivalent.
