NC PTA Balloon Dilatation Catheter

K254212 · Kossel Medtech (Suzhou) Co., Ltd. · LIT · Sep 16, 2026 · Cardiovascular

Device Facts

• Record ID: K254212
• Device Name: NC PTA Balloon Dilatation Catheter
• Applicant: Kossel Medtech (Suzhou) Co., Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 16, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

It is intended for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, to dilate the stenotic lesions of peripheral blood vessels and restore vascular patency.

Device Story

NC PTA Balloon Dilatation Catheter is an Over-the-Wire (OTW) sterile, single-use intravascular device. It consists of a two-lumen catheter (one for balloon inflation/deflation, one for 0.035" guidewire passage), a balloon, marker bands for radiopaque positioning, and a hub for connection to external pressure equipment. Used by clinicians in clinical settings to dilate stenotic lesions in peripheral vessels and restore patency. The device is advanced to the stenosis site; the balloon is inflated to dilate the vessel. The soft tip facilitates navigation. Benefits include restoration of vascular flow in peripheral arteries and veins and treatment of dialysis fistulae obstructions.

Clinical Evidence

Bench testing only. Testing included appearance, dimensional inspection, hydration, simulated use, torque strength, compatibility, balloon refolding/crossing profile, fatigue, inflation/deflation time, leakage, flexibility/kink, bond strength, tip pull, radiopacity, rated burst pressure, compliance, corrosion, packaging, and shelf-life. Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (hemolysis, complement activation, in vivo thromboresistance). All criteria met.

Technological Characteristics

OTW PTA catheter; 100cm length; 12.0-26.0mm balloon diameters; 20-80mm lengths. Materials: Nylon, Pebax, Petrothene. Non-compliant balloon. Two radiopaque marker bands. 0.035" guidewire compatibility. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for Percutaneous Transluminal Angioplasty of peripheral vasculature, including iliac arteries, iliac and femoral veins, and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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

• Atlas® Gold PTA Dilatation Catheter (K181323)

Reference Devices

• MAXI LD PTA Dilatation Catheter (K96300)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG
ADMINISTRATION

September 16, 2026

Kossel Medtech (Suzhou) Co., Ltd.
Haifeng Xie
Regulatory Affair Engineer
Bldg. 6,# 8 Jinfeng Rd.
Suzhou New District, Jiangsu 215163
China

Re: K254212

Trade/Device Name: NC PTA Balloon Dilatation Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: LIT
Dated: August 20, 2026
Received: August 20, 2026

Dear Haifeng Xie:

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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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,

GREGORY W.

O'CONNELL -S

Digitally signed by

GREGORY W. O'CONNELL -S

Date: 2026.09.16 09:58:28

-04'00'

Gregory O'Connell

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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## 510(k) SUMMARY

| Submitter: | Kossel Medtech (Suzhou) Co., Ltd. Building 6, No. 8 Jinfeng Road Suzhou New District Jiangsu 215163 China |
| --- | --- |
| Contact Person: | Haifeng Xie F3, Building 6, No. 8 Jinfeng Road Suzhou New District Jiangsu 215163 China Phone: [phone] Mail: [e-mail] |
| Date Prepared: | September 15, 2026 |
| Trade Name: | NC PTA Balloon Dilatation Catheter |
| Models: | KNCPTA120020, KNCPTA120040, KNCPTA120060, KNCPTA120080, KNCPTA140020, KNCPTA140040, KNCPTA140060, KNCPTA140080, KNCPTA160020, KNCPTA160040, KNCPTA160060, KNCPTA160080, KNCPTA180020, KNCPTA180040, KNCPTA180060, KNCPTA180080, KNCPTA200020, KNCPTA200040, KNCPTA200060, KNCPTA200080, KNCPTA220020, KNCPTA220040, KNCPTA220060, KNCPTA240020, KNCPTA240040, KNCPTA240060, KNCPTA260020, KNCPTA260040, KNCPTA260060 |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Angioplasty, Peripheral, Transluminal |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | LIT |
| Regulatory Class: | Class II |
| Predicate Device: | Atlas® Gold PTA Dilatation Catheter (K181323) |
| Reference device: | MAXI LD PTA Dilatation Catheter (K96300) |
| Device Description: | The NC PTA Balloon Dilatation Catheter is Over the Wire (OTW) PTA catheter. It is a sterile, single-use, intravascular medical device with a working |

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length of 100cm. The balloons are available in diameters 12.0-26.0mm and lengths from 20-80mm, and have a rated burst pressure of 8 atm for ø12.0-ø18.0mm and 6atm for ø20.0-ø26.0mm. The catheter is a two-lumen catheter, one lumen is used for inflation/deflation of the balloon and accessed via the lateral port of the hub. The second lumen, starting at the straight entry port of the hub, allows access to the distal tip of the catheter for guide wire insertion. The maximum recommended guide wire diameter is 0.035".

The 0.035" NC PTA Balloon Dilatation Catheter is mainly composed of tip tube, inner tube, balloon, marker bands, outer tube, stress diffusion tube and hub. The soft tip at the end of the balloon is intended to make the balloon catheter more easily to push to the stenosis position. The inner tube which connects to the tip tube is for guide wire passage and the pushing rod. The two marker bands wrapped around the inner tube are for positioning the balloon location with the use of in vitro monitoring equipment. The proximal end of the outer tube is connected with the hub, which is used as the balloon filling channel and also as the push road of the catheter. The hub is used to connect with the external pressure equipment for balloon filling. The stress diffusion tube can prevent the outer tube from being folded.

Intended Use: It is intended for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, to dilate the stenotic lesions of peripheral blood vessels and restore vascular patency.

Indications for Use: The NC PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Technological Characteristics: Comparisons of the subject device, the predicate device, and the reference device show that the technological characteristics, such as product performance, design, and intended use, support a determination of substantial equivalence between the subject device and the currently marketed predicate device.

The following table lists the material and size comparisons among the subject device, the predicate device, and the reference device.

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| Comparison items | Application Device | Predicate Device | Reference Device |
| --- | --- | --- | --- |
| | NC PTA Balloon Dilatation Catheter (Kossel Medtech (Suzhou) Co., Ltd.) | Atlas® Gold PTA Dilatation Catheter K181323 (C. R. Bard, Inc.) | MAXI LD PTA Balloon Catheter K96300 (Cordis Corporation) |
| Intended Use | It is intended for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, to dilate the stenotic lesions of peripheral blood vessels and restore vascular patency. | The Atlas® Gold PTA Dilatation Catheter is intended to dilate stenotic or obstructive lesions within the peripheral vascular system. | The Maxi Diameter Balloon PTA Dilatation Catheter is intended to dilate lesions in large vessels. |
| Indications for use | The NC PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | The Atlas® Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. | The Maxi Diameter Balloon PTA Dilatation Catheter is used for dilating stenotic segments in the peripheral arteries below the aortic arch. |

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| Target population | Patients with stenosis or obstructive lesions in specific peripheral vascular systems or with obstructive lesions in native or synthetic arteriovenous dialysis fistulas. | | Patients with stenosis or obstructive lesions in specific peripheral vascular systems or with obstructive lesions in native or synthetic arteriovenous dialysis fistulas, or needing post - dilation of stents and stent grafts in the peripheral vascular system. | Unknown |
| --- | --- | --- | --- | --- |
| Classification name | PTA Catheter | | PTA Catheter | PTA Catheter |
| Product code | LIT | | LIT, DQY | LIT |
| Chemical composition | Balloon material | Nylon, Pebax, Petrothene | Pebax, Petrothene | Unknown |
| Physical characteristics | Balloon Diameters (mm) | 12.0, 14.0, 16.0, 18.0, 20.0, 22.0, 24.0, 26.0 | 12.0, 14.0, 16.0, 18.0, 20.0, 22.0, 24.0, 26.0 | 14.0, 15.0, 16.0, 18.0, 20.0, 22.0, 25.0 |
| | Balloon lengths (mm) | 20, 40, 60, 80 | 20, 40, 60 | 40,60,80 |
| | Balloon compliance | Non-Compliant | Non-Compliant | Non-Compliant |
| | Catheter Type | OTW | OTW | OTW |
| | Marker bands | 2 markers | 2 markers | 2 markers |
| | Guide wire size (inch) | 0.035' | 0.035' | 0.035' |

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| Physical characteristics | Sheath Compatibility | 8F~14F (ø12mm~ø26mm) | 7F~12F (ø12mm~ø26mm) | Unknown |
| --- | --- | --- | --- | --- |
| | Outer tube diameter | 6F(2.00mm)/7F(2.33mm)/8F(2.67mm) | Unknown | 7F |
| | Catheter length (cm) | 100 | 80/120 | 110 |
| Physical characteristics | Rated burst Pressure (atm) | 8atm (ø12.0-18.0mm); 6atm (ø20.0-26.0mm); | 18atm (ø12.0-16.0mm); 16atm (ø16.0-20.0mm); 14atm (ø22.0-24.0mm); 12atm (ø26.0); | 6atm (ø14.0-20.0mm); 5atm (ø22.0-25.0mm); |
| | Nominal pressure (atm) | 5/6 | 4/6 | 3.5/4/6 |
| Sterilization | | EO | EO | EO |

Any differences between the subject device and predicate and reference devices do not raise new questions of safety or effectiveness. The performance testing results demonstrate that the subject device meets all predetermined acceptance criteria and in a substantially equivalent manner to the predicate device for the intended peripheral PTA application.

Performance Data: Bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows:

- Appearance inspection
- Dimensional inspection (Balloon diameter, Balloon length, Effective length of balloon catheter, Outer tube diameter, Ineer shaft diameter)
- Hydration test
- Simulated use test
- Torque strength
- Guide wire and introducer sheath compatibility test
- Balloon refolding form
- Balloon crossing profile
- Balloon fatigue test

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- • Balloon Deflation time
- • Balloon Inflation time
- • No liquid leakage
- • No air leakage
- • Flexibility and kink test
- • Catheter bond strength
- • Tip pull
- • Radiopacity
- • Balloon Rated Burst Pressure test
- • Balloon Compliance test
- • Corrosion resistance test
- • Hub dimension
- • Packaging performance test (Appearance inspection, sealing strength, Sealing integrity, Sterility)
- • Shelf-life testing

**Biocompatibility:** To demonstrate the biological safety of the body-contacting materials, the following biocompatibility testing, which was performed in accordance with 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'; 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions' were followed. Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Material-mediated pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, and In vivo thromboresistance) were conducted. The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible.

**Conclusion:** This information supports a determination of substantial equivalence between the NC PTA Balloon Dilatation Catheter and the predicate device described above.

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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. | K254212 | ? |
| Please provide the device trade name(s). | | ? |
| NC PTA Balloon Dilatation Catheter | | |
| Please provide your Indications for Use below. | | ? |
| The NC PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and femoral veins, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |