KardiFlex NC Coronary Dilatation Catheter

K202578 · Medcaptain Life Science Co., Ltd. · LOX · May 6, 2021 · Cardiovascular

Device Facts

• Record ID: K202578
• Device Name: KardiFlex NC Coronary Dilatation Catheter
• Applicant: Medcaptain Life Science Co., Ltd.
• Product Code: LOX · Cardiovascular
• Decision Date: May 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KardiFlex™ NC Coronary Dilatation Catheter is indicated for: • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. • balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. • in-stent restenosis. • post-delivery expansion of balloon expandable coronary stents.

Device Story

Rapid exchange PTCA balloon dilatation catheter; 0.014" guidewire compatible. Input: manual inflation via contrast media. Operation: balloon expansion at stenotic site to improve myocardial perfusion or expand stents. Output: mechanical dilatation of vessel/stent. Used in hospital settings by physicians. Benefits: restores blood flow in ischemic vessels or acute MI; facilitates stent deployment. Features: hydrophilic coating, platinum marker bands for positioning, non-compliant nylon balloon, PTFE-coated stainless steel hypotube.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993), mechanical performance (ISO 10555), balloon fatigue, rated burst pressure, inflation/deflation times, bond strength, and coating integrity.

Technological Characteristics

Rapid exchange PTCA catheter; 1.5-5.0mm diameter, 6-30mm length. Materials: Nylon balloon, PTFE-coated stainless steel hypotube, platinum alloy marker bands. Hydrophilic coating. Sterilization: Ethylene oxide. Standards: ISO 10555-1/4, ISO 10993, ISO 11135, ISO 11607, ISTA 3A.

Indications for Use

Indicated for patients with coronary ischemia or acute myocardial infarction requiring balloon dilatation of stenotic coronary arteries, bypass grafts, or occlusions; also for in-stent restenosis and post-delivery expansion of balloon-expandable coronary stents.

Regulatory Classification

Identification

Standard PTCA Catheter: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. Cutting/scoring PTCA Catheter: A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.

Special Controls

*Classification.* Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b) *Cutting/scoring PTCA Catheter* —(1)*Identification.* A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2) *Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.

Predicate Devices

• Sapphire NC Plus Coronary Dilatation Catheter (K192344)

Reference Devices

• Sapphire NC Coronary Dilatation Catheter (K103808)
• RX NC Takeru PTCA Balloon Dilatation Catheter (K170941)

Submission Summary (Full Text)

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May 6, 2021

Medcaptain Life Science Co., Ltd. David Xia Official Correspondent 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen, Guangdong 518118 China

Re: K202578

Trade/Device Name: KardiFlexTM NC Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: September 3, 2020 Received: September 8, 2020

Dear David Xia:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202578

Device Name

KardiFlex NC Coronary Dilatation Catheter

Indications for Use (Describe)

KardiFlex NC Coronary Dilatation Catheter is indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

- · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
- · in-stent restenosis.
- · post-delivery expansion of balloon expandable coronary stents.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div> <input checked="true" type="checkbox"/> <span>Prescription Use (Part 81 CFR 201 Subpart D)</span> </div> |
|----------------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> <span>Over-The-Counter Use (81 CFR 201 Subpart C)</span> </div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for MEDCAPTAIN. The text "MED" is in gray, and "CAPTAIN" is in blue. To the right of the text is an open quotation mark in blue and orange. Above the text is Chinese characters in gray.

MEDCAPTAIN LIFE SCIENCE CO., LTD. 601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Email: [e-mail] Tel.: [phone] Fax.: [phone] Website: www.medcaptain.com

# 510(k) Summary

# KardiFlexTM NC Coronary Dilatation Catheter 21 CFR §870.5100(a) Date prepared: May 1, 2021

This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).

## I. Submitter/510(k) Holder

| Submission: | Traditional 510(k) Premarket Notification |
|-------------|----------------------------------------------------------------------------------------------------|
| Submitter: | Medcaptain Life Science Co., Ltd. |
| Address: | 601, Building C, Jinweiyuan Industrial Park, Pingshan<br>District, Shenzhen, Guangdong, CN 518118. |
| Contact: | David Xia |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Email: | [e-mail] |

## II. Device information

| Device Trade Name: | KardiFlexTM NC Coronary Dilatation Catheter |
|----------------------------|-------------------------------------------------------------------|
| Device Common Name: | Percutaneous Transluminal Coronary Angioplasty<br>(PTCA) Catheter |
| Classification Name: | Catheter, transluminal coronary angioplasty,<br>percutaneous |
| Classification Regulation: | 21 CFR 870.5100(a) |
| Product Code: | LOX |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
| 510(k) Number: | K202578 |

## III. Predicate Device

The KardiFlex™ NC Coronary Dilatation Catheter is substantially equivalent to the following devices:

Predicate device: Sapphire NC Plus Coronary Dilatation Catheter (K192344, OrbusNeich Medical Trading, Inc.) cleared on September 19, 2019.

Reference device 1: Sapphire NC Coronary Dilatation Catheter (K103808,

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Image /page/4/Picture/2 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is displayed in a sans-serif font, with "MED" in gray and "CAPTAIN" in blue. To the right of the word "CAPTAIN" is an orange graphic that resembles a speech bubble or a bracket. Above the logo are some gray Japanese characters.

601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: [phone] Email: [e-mail] Fax.: [phone] Website: www.medcaptain.com

OrbusNeich Medical, Inc.) cleared on September 1, 2011.

And, reference device 2: RX NC Takeru PTCA Balloon Dilatation Catheter (K170941, Kaneka Corporation) were used in this submission.

# IV. Device Description

The KardiFlex™ NC Coronary Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 5.0mm and lengths from 6mm to 30mm. The balloon material is made of a minimally Nylon material and balloons have a rated burst pressure of 22 atmospheres. The minimally material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.

The KardiFlex™ NC Coronary Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-5.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube).

The KardiFlex™ NC Coronary Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

## V. Indications for Use

KardiFlex™ NC Coronary Dilatation Catheter is indicated for:

- balloon dilatation of the stenotic portion of a coronary artery or bypass graft . stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
- balloon dilatation of a coronary artery occlusion for the treatment of acute . myocardial infarction.
- in-stent restenosis. .
- post-delivery expansion of balloon expandable coronary stents. ●

## VI. Comparison to Predicate Device

The subject device, KardiFlex™ NC Coronary Dilatation Catheter, and the predicate device, Sapphire NC Plus Coronary Dilatation Catheter, are substantially equivalent in that these devices, at a high level, have same technological element: intended use, indications for use, operation principle and design (such as rapid exchange catheter

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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601 Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: [phone] Email: [e-mail] Fax.: [phone] Website: www.medcaptain.com

design, hydrophilic coating applied in the distal section, non-compliant balloon, 0.014inch guidewire compatibility, EO sterilization and single use), prescription use, target user, use environment, main materials, nominal pressure, etc.

The technological differences between the subject and the predicate device include balloon diameter range, balloon length range, working length, rated burst pressure. Testing requirements for the subject device are based on upon the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).

Similarities and differences in technologies characteristics are captured in the substantial equivalence comparison of the subject device, KardiFlex™ NC Coronary Dilatation Catheter, and the predicate device, Sapphire NC Plus Coronary Dilatation Catheter, which are provided in Table 1.

| Description | Sapphire NC Plus<br>Coronary Dilatation<br>Catheter<br>(Predicate Device) | Sapphire NC<br>Coronary Dilatation<br>Catheter<br>(Reference Device 1) | RX NC Takeru<br>(Reference Device 2) | KardiFlexTM NC<br>Coronary Dilatation<br>Catheter<br>(Subject device) | Comparison to<br>predicate/refer<br>ence device | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Number | K192344 | K103808 | K170941 | K202578 | N/A | |
| Regulation Number | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | 21 CFR 870.5100 | 21 CFR 870.5100(a) | Identical | |
| Classification Name | Catheter, transluminal<br>coronary angioplasty,<br>percutaneous | Catheter, transluminal<br>coronary angioplasty,<br>percutaneous | Percutaneous<br>Transluminal Coronary<br>Angioplasty (PTCA)<br>Catheter | Catheter, transluminal<br>coronary angioplasty,<br>percutaneous | Identical | |
| Product Code | LOX | LOX | LOX | LOX | Identical | |
| Device Class | Class II | Class II | Class II | Class II | Identical | |
| Intended Use | Sapphire NC Plus<br>Coronary Dilatation<br>Catheter is intended<br>for use in<br>percutaneous<br>transluminal<br>coronary<br>angioplasty (PTCA)<br>to treat patients with<br>coronary disease. | Sapphire NC Coronary<br>Dilatation Catheter is<br>intended for use in<br>percutaneous<br>transluminal coronary<br>angioplasty (PTCA) to<br>treat patients with<br>coronary disease. | RX NC Takeru<br>Coronary Dilatation<br>Catheter is intended<br>for use in<br>percutaneous<br>transluminal coronary<br>angioplasty (PTCA) to<br>treat patients with<br>coronary disease. | KardiFlexTM NC<br>Coronary Dilatation<br>Catheter is intended<br>for use in<br>percutaneous<br>transluminal<br>coronary<br>angioplasty (PTCA)<br>to treat patients with<br>coronary disease. | Identical | |
| Indications for use | Sapphire NC Plus | Sapphire NC Coronary | The RX NC Takeru | KardiFlexTM NC | Identical to | |
| | Coronary Dilatation<br>Catheter is indicated<br>for: | Dilatation Catheter is<br>indicated for:<br>• balloon dilatation of<br>the stenotic portion of<br>a coronary artery or<br>bypass graft stenosis<br>in patients evidencing<br>coronary ischemia for<br>the purpose of<br>improving myocardial<br>perfusion.<br>• balloon dilatation of<br>a coronary artery<br>occlusion for the<br>treatment of acute<br>myocardial infarction.<br>•in-stent restenosis<br>•post-delivery<br>expansion of balloon<br>expandable coronary<br>stents. | PTCA Balloon<br>Dilatation Catheter is<br>indicated for balloon<br>dilatation of the stenotic<br>portion in coronary<br>artery or bypass graft<br>stenosis for the purpose<br>of myocardial<br>perfusion.<br>This product is also<br>indicated for the<br>post-delivery expansion<br>of balloon expandable<br>stents | Coronary Dilatation<br>Catheter is indicated<br>for:<br>• balloon dilatation<br>of the stenotic<br>portion of a<br>coronary artery or<br>bypass graft stenosis<br>in patients<br>evidencing coronary<br>ischemia for the<br>purpose of<br>improving<br>myocardial<br>perfusion.<br>• balloon dilatation<br>of a coronary artery<br>occlusion for the<br>treatment of acute<br>myocardial<br>infarction.<br>•in-stent restenosis<br>•post-delivery<br>expansion of balloon<br>expandable coronary<br>stents. | predicate device | |
| Operation principle<br>and design | Sapphire NC Plus<br>Coronary Dilatation<br>Catheteris<br>a<br>percutaneous<br>transluminal coronary<br>angioplasty (PTCA)<br>balloon catheter with<br>a working length of<br>140cm.The proximal<br>shaft is a polymer<br>coated stainless steel<br>hypotube. Lubricious<br>coatings are applied to<br>the distal section. The | Sapphire NC Coronary<br>Dilatation Catheter is a<br>percutaneous<br>transluminal coronary<br>angioplasty (PTCA)<br>balloon catheter with a<br>working length of<br>140cm. The proximal<br>shaft is a polymer<br>coated stainless steel<br>hypotube. Lubricious<br>coatings are applied to<br>the distal section. The<br>non-compliant balloons | RX NC Takeru PTCA<br>Balloon Dilatation<br>Catheter is a<br>percutaneous<br>transluminal coronary<br>angioplasty (PTCA)<br>balloon catheter with a<br>working length of<br>145cm. RX NC Takeru<br>is a rapid exchange type<br>of balloon dilatation<br>catheter, which consists<br>of a distal tube,<br>guidewire transition | KardiFlexTM NC<br>Coronary Dilatation<br>Catheter is a<br>percutaneous<br>transluminal coronary<br>angioplasty (PTCA)<br>balloon catheter with<br>a working length of<br>142.5cm design. The<br>proximal shaft is a<br>PTFE coated stainless<br>steel hypotube.<br>Hydrophilic coatings<br>are applied to the | Substantially<br>equivalent<br><br>Differences do<br>not raise new or<br>different<br>questions<br>regarding safety<br>or effectiveness. | |
| non-compliant | | can be inflated by | tube, balloon, radiopaque markers, mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. RX NC Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire. The maximum compatible diameter of a guidewire is 0.014inches. Guiding catheters with a diameter of 5 or 6Fr have been deemed to be compatible with the RX NC Tekeru. | distal section. The non-compliant balloons can be inflated by injection of dilute contrast media solution through the hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment (only one centrally located marker band for 1.5 configurations).The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with s single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position. The design of this dilatation catheter does not | | |
| balloons can be inflated by injection dilute contrast media solution through the trailing hub of the catheter.Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire.The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with s single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure | | injection dilute contrast media solution through the trailing hub of the catheter. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014inch PTCA guidewire. The proximal part of the guidewire enters the catheter tip and advances coaxially out the catheter proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with s single standard length guidewire. Two marked sections are located on the hypotube shaft to indicate catheter position. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements. | | | | |
| | measurements. | | | incorporate a lumen<br>for distal dye<br>injections or distal<br>pressure<br>measurements. | | |
| Prescription/<br>Over-the-Counter | Prescription | Prescription | Prescription | Prescription | Identical | |
| Target User | Intended for use by<br>physicians | Intended for use by<br>physicians | Intended for use by<br>physicians | Intended for use by<br>physicians | Identical | |
| Access/ Anatomical<br>site: | Inserted<br>percutaneously into<br>the arterial circulation<br>or bypass graft<br>stenosis | Inserted percutaneously<br>into the arterial<br>circulation or bypass<br>graft stenosis | / | Inserted<br>percutaneously into<br>the arterial circulation<br>or bypass graft<br>stenosis | Identical to<br>predicate device | |
| Use environment: | Hospitals | Hospitals | / | Hospitals | Identical to<br>predicate device | |
| Materials: | / | / | / | / | / | |
| Balloon material | Nylon | Nylon…