Zenith Distal Access Long Sheath

K253359 · Suzhou Zenith Vascular SciTech Limited · QJP · May 22, 2026 · Cardiovascular

Device Facts

• Record ID: K253359
• Device Name: Zenith Distal Access Long Sheath
• Applicant: Suzhou Zenith Vascular SciTech Limited
• Product Code: QJP · Cardiovascular
• Decision Date: May 22, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Indications for Use

The Zenith Distal Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Story

The Zenith Distal Access Long Sheath is a sterile, single-use, single-lumen, variable stiffness composite catheter designed for percutaneous access. It functions as a conduit for the introduction of interventional devices (e.g., guidewires, catheters, stent retrievers) into the peripheral, coronary, and neuro vasculature. The device is operated by a physician in a clinical setting. It features a hydrophilic coating to reduce friction, a radiopaque marker for fluoroscopic visualization, and a graded shaft stiffness to facilitate tracking over guidewires. The system includes a dilator, hemostasis valve, and Y-type valve. The physician advances the sheath over a guidewire to the target site; once positioned, the dilator is removed, and interventional devices are introduced through the lumen. The device aids in navigating complex anatomy, potentially improving procedural success and patient outcomes by providing stable access for therapeutic interventions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench performance testing, including dimensional verification, simulated use in anatomical models, tensile strength, flexibility/kink resistance, torque strength, coating lubricity, particulate evaluation, and biocompatibility testing (ISO 10993 series).

Technological Characteristics

Variable stiffness composite catheter; 8F (0.106" OD, 0.090" ID); lengths 70-105 cm. Materials: PTFE inner layer, stainless steel braid, polyurethane/polyamide/nylon outer jacket, platinum-iridium radiopaque marker. Hydrophilic coating. Sterilization: Ethylene Oxide (EO). Standards: ISO 10555-1 (catheter performance), ISO 80369-7/20 (hubs/connectors), ISO 10993 (biocompatibility), ISO 11135 (sterilization).

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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

• Neuron™ MAX System (K111380)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

May 22, 2026

Suzhou Zenith Vascular SciTech Limited
Yexia Zhang
Senior Regulatory Affair Supervisor
Unit 101, Building 6, Block B, Phase 5, Biobay
No.21 Dongyanli Road, SIP Suzhou
Suzhou, Jiangsu 215123
China

Re: K253359
Trade/Device Name: Zenith Distal Access Long Sheath
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP, DQY
Dated: April 20, 2026
Received: April 20, 2026

Dear Yexia Zhang:

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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K253359 - Yexia Zhang
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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,

NAIRA MURADYAN -S

Naira Muradyan, Ph.D.
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) K253359 | |
| Device Name Zenith Distal Access Long Sheath | |
| Indications for Use (Describe) The Zenith Distal Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | |
| 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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中天医疗
Zenith Vascular

Zenith Distal Access Long Sheath K253359

# 510(k) Summary-K253359

| Applicant | Suzhou Zenith Vascular SciTech Limited Unit 101, Building 6, Block B, Phase 5, Biobay, No.21 Dongyanli Road, SIP Suzhou, China 215123 | |
| --- | --- | --- |
| Contact Person | Yexia Zhang | Xiaoyu Wang |
| Email | [e-mail] | [e-mail] |
| Tel | [phone] | |
| Date Prepared | May 20, 2026 | |
| Device Trade Name | Zenith Distal Access Long Sheath | |
| Regulation Number | 21 CFR 870.1250 | |
| Regulation Name | Percutaneous Catheter | |
| Product Code | QJP, DQY | |
| Device Classification | Class II | |
| Predicate Device | Neuron™ MAX System (K111380) | |

# Device Description

The Zenith Distal Access Long Sheath is a sterile, single-use, single-lumen, variable stiffness composite catheter. It has an inner diameter (ID) of $0.090''$ , an outer diameter (OD) of $0.106''$ corresponding to 8 French (F), and is offered in five working lengths: $70~\mathrm{cm}$ , $80~\mathrm{cm}$ , $90~\mathrm{cm}$ , $100~\mathrm{cm}$ , and $105~\mathrm{cm}$ . The device features two tip shapes: straight and curved (identified by the suffix "MP" in the model code). The device incorporates a radiopaque marker at the distal end for angiographic visualization. It is supplied with one Dilator, one Hemostasis Valve, and one Y-type valve.

The proximal end of each Zenith Distal Access Long Sheath incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Graded shaft stiffness ranging from a flexible tip to a semi-rigid proximal section aids the physician in tracking the sheath over selectively placed catheters/guidewires.

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中天医疗
Zenith Vascular

Zenith Distal Access Long Sheath K253359

# Indications for Use

The Zenith Distal Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

# Predicate Device Comparison

The predicate device for the Zenith Distal Access Long Sheath is the Neuron™ MAX System (K111380). The table below describes the technological similarities and differences between them.

Table 1. Comparison of Subject and Predicate Devices

| Attributes | Subject Device (K253359) | Predicate Device (K111380) |
| --- | --- | --- |
| Device Name | Zenith Distal Access Long Sheath | Neuron™ MAX System |
| Indications for Use | The Zenith Distal Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The Neuron MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Regulation No. | 21 CFR 870.1250 | 21 CFR 870.1250 |
| Regulatory Class | II | II |
| Product Code | QJP, DQY | DQY |
| OD | 0.106 inch (8 French) | 0.110 inch (8 French) |
| ID | 0.090 inch | 0.088 inch |
| Effective Length | 70-105 cm | 70-100 cm |
| Tip shape | Straight/Curved | Straight/Curved |
| Dilator ID | 0.040 inch | 0.040 inch |
| Dilator OD | 0.085 inch | 0.084 inch |
| Dilator Effective Length | 90-125 cm | 90-125 cm |
| Inner Layer | Polytetrafluoroethylene (PTFE) | PTFE |
| Braid | Stainless steel | Stainless steel |
| Radiopaque Marker | Platinum-Iridium alloy | Platinum-Iridium alloy |
| Outer Jacket | Polyurethane, Polyamide, Nylon | Polyurethane, Polyether block amide materials |
| Coating | Hydrophilic | Hydrophilic |
| Hub | Polycarbonate | Polyamide |
| Strain Relief | Polyurethane | Stainless Steel |
| Accessories | Dilator, Hemostasis Valve, Y-type Valve | Dilator, Rotating Hemostasis Valve, 6F Select Catheter |
| Packaging Configuration | Placed into the Cardboard, protective tubes, Tyvek pouch, and box carton. | Placed into the Cardboard, protective tubes, Tyvek pouch, and box carton. |
| Sterilization Method | Ethylene Oxide (EO) | EO |

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中天医疗
Zenith Vascular

Zenith Distal Access Long Sheath K253359

| Attributes | Subject Device (K253359) | Predicate Device (K111380) |
| --- | --- | --- |
| Shelf Life | 24 Months | 36 Months |

# Performance Data

Non-clinical tests have been conducted to support substantial equivalence of the subject device to the predicate device and are summarized below.

# Performance Testing-Bench

The following bench performance testing was performed to evaluate the Zenith Distal Access Long Sheath.

Table 2. Bench Performance Testing - Zenith Distal Access Long Sheath

| Test | Test Method Summary | Results | Conclusion |
| --- | --- | --- | --- |
| Dimensional Verification | The dimensions (inner diameter, outer diameter, effective length, hydrophilic coating length, radiopaque marker width) of the Zenith Distal Access Long Sheath and Dilator were measured. | Pass | Zenith Distal Access Long Sheath and Dilator met the acceptance criteria. |
| Surface Inspection | The Zenith Distal Access Long Sheath and accessories were visually inspected under microscopy. | Pass | Zenith Distal Access Long Sheath met the acceptance criteria. |
| Distal Tip Inspection | The distal tip of the Zenith Distal Access Long Sheath and the Dilator were inspected for defects. | Pass | Distal tip met the acceptance criteria. |
| Corrosion Resistance | The Zenith Distal Access Long Sheath was tested according to ISO 10555-1, Annex A. | Pass | Zenith Distal Access Long Sheath showed no signs of corrosion. |
| Device Compatibility | Sheath-Dilator Compatibility, Dilator-Guidwire Compatibility, and Sheath-Catheter Compatibility were tested in the simulated use. | Pass | Device compatibility of Zenith Distal Access Long Sheath met the acceptance criteria |
| Simulated Use | The Zenith Distal Access Long Sheath and Dilator were evaluated in a simulated anatomical model with a 0.035” guidewire, a 6F guide catheter and a representative worst-case interventional device (neurovascular stent retriever retracted through the inner lumen of the Zenith Distal Access Long Sheath for 3 passes). Tracking, advancement force, withdrawal force, performance, and post-simulated use integrity were verified. | Pass | Zenith Distal Access Long Sheath met the acceptance criteria. |
| Peak Tensile Force | The Zenith Distal Access Long Sheath and Dilator were evaluated to verify the peak tensile force of the full system after preconditioning meets the minimum tensile strength requirement. | Pass | Zenith Distal Access Long Sheath and Dilator met the acceptance criteria. |
| Tip Pull Test | The Zenith Distal Access Long Sheath was evaluated via tip pull test after preconditioning with devices. | Pass | Zenith Distal Access Long Sheath met the acceptance criteria. |
| Flexibility and Kink Test | The Zenith Distal Access Long Sheath and Dilator were evaluated for resistance to kinking around bends with clinically relevant bend radii after preconditioning. | Pass | Zenith Distal Access Long Sheath met the acceptance criteria. |
| Torque Strength | The Zenith Distal Access Long Sheath and Dilator were evaluated for torque strength by rotating the test samples in an anatomical model with the distal tip fixed and recording the failure location, failure mode, and number of rotations to failure after preconditioning. | Pass | Zenith Distal Access Long Sheath and a cleared comparator showed a similar number of rotations to failure. |

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中天医疗
Zenith Vascular
Zenith Distal Access Long Sheath
K253359

| Coating Integrity | The Zenith Distal Access Long Sheath coating integrity was inspected pre- and post- simulated use in an anatomical model. | Pass | Zenith Distal Access Long Sheath met the acceptance criteria. |
| --- | --- | --- | --- |
| Coating Lubricity | The Zenith Distal Access Long Sheath was evaluated for frictional forces of the hydrophilic coated regions on a universal testing machine after preconditioning. | Pass | Zenith Distal Access Long Sheath and the predicate device showed similar frictional forces. |
| Particulate Evaluation | The Zenith Distal Access Long Sheath and Dilator were evaluated for particulate generation during simulated use with ancillary devices in an anatomical model. | Pass | Zenith Distal Access Long Sheath and the predicate device showed similar particle numbers. |
| Tip Stiffness | The distal tip of the Zenith Distal Access Long Sheath and Dilator were deflected on a universal testing machine to characterize bending forces before preconditioning. | Pass | The Zenith Distal Access Long Sheath and its dilator exhibited tip stiffness similar to that of the predicate device. |
| Hub Testing | The hub of the Zenith Distal Access Long Sheath and hub of Dilator were tested according to ISO 80369-7 and ISO 80369-20. | Pass | Zenith Distal Access Long Sheath hub and Dilator hub met the acceptance criteria. |
| Hemostasis Valve and Y-type Valve | The Hemostasis Valve and Y-type Valve were tested according to ISO 80369-7 and ISO 80369-20 | Pass | The Hemostasis Valve and Y-type Valve met the acceptance criteria. |
| Static Burst Pressure | The Zenith Distal Access Long Sheath was tested for static burst pressure according to the methods specified in ISO 10555-1:2023, Annex F. | Pass | Zenith Distal Access Long Sheath met the acceptance criteria. |
| Liquid Leakage | The Zenith Distal Access Long Sheath and Dilator were tested according to ISO 10555-1, Annex C. | Pass | Zenith Distal Access Long Sheath and Dilator showed no leakage. |
| Air Leakage | The Zenith Distal Access Long Sheath and Dilator were tested according to ISO 10555-1, Annex D. | Pass | Zenith Distal Access Long Sheath and Dilator showed no leakage. |
| Radiopacity | The Zenith Distal Access Long Sheath was visualized under fluoroscopy. | Pass | Zenith Distal Access Long Sheath and the predicate device were imaged showing equivalence in terms of radiopacity. |

The performance data demonstrate that the subject device is substantially equivalent to the predicate device.

## Biocompatibility Test

Biocompatibility tests were conducted with the Zenith Distal Access Long Sheath in accordance with ISO 10993-1:2018, “Biological evaluation of medical devices-Evaluation and testing within a risk management process” and 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".” The tests performed are listed in Table 3.

Table 3. Biocompatibility Testing

| Test | Standards | Results | Conclusion |
| --- | --- | --- | --- |
| ISO MEM Elution Test with L-929 Cells | ISO 10993-5 | The test article had a reactivity grade of ≤ 2 under the conditions of this study. | Non-cytotoxic |
| ISO Guinea Pig Maximization Sensitization Test (2 Extracts) | ISO 10993-10 | The saline and sesame oil test article extracts did not show evidence of causing delayed dermal contact | Non-sensitizer |

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中天医疗
Zenith Vascular
Zenith Distal Access Long Sheath
K253359

| | | sensitization response in the guinea pigs. | |
| --- | --- | --- | --- |
| Intracutaneous Reactivity Test in Rabbits (2 Extracts) | ISO 10993-23 | The differences between the test extracts and their respective control mean scores were less than 1.0. | Non-irritant |
| Acute Systemic Toxicity Study in Mice (2 Extracts) | ISO 10993-11 | There was no mortality or evidence of acute systemic toxicity from the extracts. | No evidence of acute systemic toxicity |
| Material-Mediated Pyrogenicity Test in Rabbits (Saline Extract) | ISO 10993-11 | None of the test rabbits exhibited a temperature rise greater than or equal to 0.5°C. | Non-pyrogenic |
| ASTM Hemolysis Test - Direct Contact and Extract Methods | ISO 10993-4 | The test article hemolytic index was above the negative control and was less than 2% for both direct contact and extract methods under the conditions of this study. | Non-hemolytic |
| Complement Activation SC5b-9 Assay (with Comparator Control Article) | ISO 10993-4 | The concentration of SC5b-9 activated by the test article was statistically lower than that activated by the negative reference material and comparator control article. | Not an activator |
| Non-anticoagulated Venous Implant Study in Canines for Evaluation of Thromboresistance | ISO 10993-4 | The extent of thrombus formation on the test article was not greater than the comparator control article. | Non-thrombogenic |

## Sterilization and Shelf Life

The Zenith Distal Access Long Sheath is sterilized using ethylene oxide (EO) method. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10⁻⁶ 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.”

Aging studies for the subject device have been conducted to support the 2 year shelf-life. Packaging tests were also conducted and the results met all acceptance criteria.

## Packaging

Each package consists of a Sterile Barrier System (SBS) and protective packaging. SBS validation was conducted per requirements of ISO 11607-2, “Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes.”

## Animal Study

An animal study was not deemed necessary to support the substantial equivalence of the subject device to the predicate device. Non-clinical testing described above was determined to be sufficient to support substantial equivalence.

## Clinical Studies

Clinical testing was not deemed necessary to support the substantial equivalence of the subject device to the predicate device. Non-clinical testing described above was determined to be sufficient to support substantial equivalence.

## Conclusion

The subject and predicate devices have the same intended use and similar technological characteristics. The

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中天医疗
Zenith Vascular
Zenith Distal Access Long Sheath
K253359

non-clinical testing demonstrates that the subject device performs as intended and supports substantial equivalence to the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness.

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