KardiFlex PTCA Balloon Dilatation Catheter

K202619 · Medcaptain Life Science Co., Ltd. · LOX · Apr 29, 2021 · Cardiovascular

Device Facts

• Record ID: K202619
• Device Name: KardiFlex PTCA Balloon Dilatation Catheter
• Applicant: Medcaptain Life Science Co., Ltd.
• Product Code: LOX · Cardiovascular
• Decision Date: Apr 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KardiFlex PTCA Balloon 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.

Device Story

Rapid exchange PTCA balloon dilatation catheter; used for balloon dilatation of stenotic coronary arteries or bypass grafts; compatible with 0.014" guidewires; operated by physicians in hospital settings; device consists of hub, hypotube, distal shaft, and semi-compliant balloon; balloon inflated via contrast media injection; radiopaque platinum markers aid positioning; hydrophilic coating on distal section; device improves myocardial perfusion by dilating stenotic vessels; single-use, sterile, non-pyrogenic.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993), dimensional verification, balloon rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, tip pull, flexibility/kink, torque, coating integrity, particulate evaluation, and sterilization validation.

Technological Characteristics

Rapid exchange PTCA catheter; PTFE-coated stainless steel hypotube; semi-compliant balloon (Pebax); platinum alloy marker bands; hydrophilic coating; 0.014" guidewire compatible; 1.5-4.0mm diameter; 6-30mm length; 16 atm rated burst pressure; EO sterilization.

Indications for Use

Indicated for patients with coronary ischemia or acute myocardial infarction requiring balloon dilatation of stenotic coronary arteries or bypass grafts.

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 II Pro Coronary Dilatation Catheter (K163114)

Reference Devices

• Sapphire Coronary Dilatation Catheter (K103657)
• Sapphire II PRO Balloon Dilatation Catheter (K180921)
• Selethru PTCA Balloon Dilatation Catheter (K182699)

Submission Summary (Full Text)

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April 29, 2021

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

Re: K202619

Trade/Device Name: KardiFlex™ PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: March 30, 2021 Received: April 1, 2021

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 mav, 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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Gregory W. O'connell. The date of the signature is 2021.04.29, and the time is 10:10:13 -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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# Indications for Use

510(k) Number (if known) K202619

Device Name KardiFlex PTCA Balloon Dilatation Catheter

Indications for Use (Describe)

KardiFlex PTCA Balloon 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.

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

| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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MEDCAPTAIN LIFE SCIENCE CO., LTD. 601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118. Tel.: [phone] Email: [e-mail] Website: www.medcaptain.com Fax.: [phone]

# 510(k) Summary

# KardiFlex™ PTCA Balloon Dilatation Catheter 21 CFR §870.5100(a) Date prepared: April 29, 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 |
| | District, Shenzhen, Guangdong, CN 518118. |
| Contact: | David Xia |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Email: | [e-mail] |

## II. Device information

| Device Trade Name: | KardiFlex™ PTCA Balloon Dilatation Catheter |
|----------------------------|-------------------------------------------------------------------|
| Device Common Name: | Percutaneous Transluminal Coronary Angioplasty<br>(PTCA) Catheter |
| Classification Name: | Catheter, transluminal coronary angioplasty, percutaneous |
| Classification Regulation: | 21 CFR 870.5100(a) |
| Product Code: | LOX |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
| 510(k) Number: | K202619 |

# III. Predicate Device

The KardiFlex™ PTCA Balloon Dilatation Catheter is substantially equivalent to the following device:

Predicate Device: Sapphire II Pro Coronary Dilatation Catheter (K163114, OrbusNeich Medical, Inc.) cleared on May 1, 2017.

The following reference devices are used in this submission: Reference Device 1: Sapphire Coronary Dilatation Catheter (K103657, OrbusNeich

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

Medical, Inc.) cleared on August 9, 2011.

Reference Device 2: Sapphire II PRO Balloon Dilatation Catheter (K180921, OrbusNeich Medical Trading, Inc.) cleared on June 28, 2018.

Reference Device 3: Selethru PTCA Balloon Dilatation Catheter (K182699, Kossel Medtech (Suzhou) Co., Ltd.) cleared on November 26, 2018.

# IV. Device Description

The KardiFlex™ PTCA Balloon 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 4.0mm and lengths from 6mm to 30mm. The balloon material is made of compliant material and balloons have a rated burst pressure of 16 atmospheres. The compliant material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.

The KardiFlex™ PTCA Balloon Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-4.0mm) 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 "10 PTCA Balloon 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™ PTCA Balloon 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.

## VI. Comparison to Predicate Device

The subject device, KardiFlex™ PTCA Balloon Dilatation Catheter, and the predicate device, Sapphire II Pro Coronary Dilatation Catheter , are substantially equivalent in that these devices, at a high level, have the same technological characteristics: intended use, indications for use, operation principle and design (such as rapid exchange catheter design, hydrophilic coating applied in the distal section, semi-compliant balloon, 0.014inch guidewire compatibility, EO sterilization

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

and single use), prescription use, target user, use environment, balloon diameter, etc.

The differences between the subject and the predicate devices include balloon length range, working length, rated burst pressure 16 atm (vs. 14atm.), etc., do not raise new or different questions for regarding safety or effectiveness. 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™ PTCA Balloon Dilatation Catheter, and the predicate device, Sapphire II Pro Coronary Dilatation Catheter, which are provided in Table 1.

## Table 1: Substantial Equivalence

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601Building C, Jinweiyuan Industrial Park, Pingshan District,

Shenzhen, Guangdong, CN 518118.

Tel.: [phone] Fax.: [phone] Email: [e-mail]

Website: www.medcaptain.com

| Description | Sapphire II Pro Coronary<br>Dilatation Catheter<br>(Predicate Device) | Sapphire Coronary<br>Dilatation Catheter<br>(Reference Device 1) | Sapphire II PRO<br>Balloon Dilatation<br>Catheter<br>(Reference Device 2) | Selethru PTCA Balloon<br>Dilatation Catheter<br>(Reference Device 3) | KardiFlexTM PTCA<br>Balloon Dilatation<br>Catheter<br>(Subject device) | Comparison to<br>predicate/reference<br>device |
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| 510(k) Number | K163114 | K103657 | K180921 | K182699 | K202619 | N/A |
| Regulation Number | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | 21 CFR 870.5100(a) | Identical |
| Classification Name | Catheter, transluminal coronary<br>angioplasty, percutaneous | Catheter, transluminal<br>coronary angioplasty,<br>percutaneous | Catheter, transluminal<br>coronary angioplasty,<br>percutaneous | Catheter, transluminal<br>coronary angioplasty,<br>percutaneous | Catheter, transluminal<br>coronary angioplasty,<br>percutaneous | Identical |
| Product Code | LOX | LOX | LOX(primary)<br>LIT(secondary) | LOX | LOX | Identical to predicate<br>device |
| Device Class | Class II | Class II | Class II | Class II | Class II | Identical |
| Intended Use | Sapphire II Pro Coronary<br>Dilatation Catheter is intended<br>for use in percutaneous<br>transluminal coronary<br>angioplasty (PTCA) to treat<br>patients with coronary disease. | Sapphire Coronary<br>Dilatation Catheter is<br>intended for use in<br>percutaneous transluminal<br>coronary angioplasty<br>(PTCA) to treat patients<br>with coronary disease. | Sappgire II Pro Balloon<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. | The Selethru PTCA<br>Balloon Dilatation<br>Catheter is indicated for<br>balloon dilatation of the<br>stenotic portion of a<br>coronary artery or<br>bypass graft stenosis for<br>the purpose of<br>improving myocardial<br>perfusion. | KardiFlexTM PTCA<br>Balloon 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. | Identical to predicate<br>device |
| Indications for use | The Sapphire II PRO coronary<br>dilatation catheter is indicated<br>for: | The Sapphire coronary<br>dilatation catheter is<br>indicated for: | The Sapphire® II PRO<br>balloon dilatation catheter | The Selethru PTCA<br>Balloon Dilatation | KardiFlexTM PTCA<br>Balloon Dilatation | Identical to predicate<br>device |
| | • balloon dilatation of the<br>stenotic portion of a coronary<br>artery or bypass graft stenosis<br>in patients evidencing<br>coronary ischemia for the<br>purpose of improving<br>myocardial perfusion.<br>• balloon dilatation of a<br>coronary artery occlusion for<br>the treatment of acute<br>myocardial infarction. | • balloon dilatation of the<br>stenotic portion of a<br>coronary artery or bypass<br>graft stenosis in patients<br>evidencing coronary<br>ischemia for the purpose<br>of improving myocardial<br>perfusion.<br>• balloon dilatation of a<br>coronary artery occlusion<br>for the treatment of acute<br>myocardial infarction. | (1.5-4.0mm<br>configuration) is indicated<br>for:<br>• balloon dilatation of<br>the stenotic portion of a<br>coronary artery or<br>bypass graft stenosis in<br>patients evidencing<br>coronary ischemia for<br>the purpose of<br>improving myocardial<br>perfusion.<br>• balloon dilatation of a<br>coronary artery<br>occlusion for the<br>treatment of acute<br>myocardial infarction. | Catheter is indicated for<br>balloon dilatation of the<br>stenotic portion of a<br>coronary artery or<br>bypass graft stenosis for<br>the purpose of<br>improving myocardial<br>perfusion. | Catheter is indicated<br>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. | |
| Operation principle<br>and design | Sapphire II PRO Coronary<br>Dilatation Catheter is a<br>percutaneous transluminal<br>coronary angioplasty (PTCA)<br>balloon catheter with a working<br>length of 140cm. The proximal<br>shaft is a PTFE coated stainless | Sapphire Coronary<br>Dilatation Catheter is a<br>percutaneous transluminal<br>coronary angioplasty<br>(PTCA) balloon catheter<br>with a working length of<br>140cm. The proximal shaft | Sapphire II PRO Balloon<br>Dilatation Catheter is a<br>rapid exchange balloon<br>catheter with a working<br>length of 140cm design<br>for both coronary and<br>peripheral indications. | The Selethru PTCA<br>Balloon Dilatation<br>Catheter is a rapid<br>exchange (RX) PTCA<br>Balloon Catheter, sterile,<br>single use, intravascular<br>medical device with a | KardiFlexTM PTCA<br>Balloon Dilatation<br>Catheter is a rapid<br>exchange balloon<br>catheter with a working<br>length of 142.5cm<br>design. The proximal | Substantially<br>equivalent<br>Differences do not<br>raise new or different<br>questions regarding<br>safety or effectiveness. |

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601Building C, Jinweiyuan Industrial Park, Pingshan District,

Shenzhen, Guangdong, CN 518118.

Tel.: [phone] Fax.: [phone]

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601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118.

MEDCAPTAIN LIFE SCIENCE CO., LTD.

Tel.: [phone] Fax.: [phone] Email: [e-mail]

Website: www.medcaptain.com

| steel hypotube. Hydrophilic<br>lubricious coatings are applied<br>to the distal section. The<br>semi-compliant balloons can be<br>inflated by injection dilute<br>contrast media solution through<br>the trailing hub of the catheter.<br>Two radiopaque platinum<br>marker bands are located within<br>the balloon segment (only one<br>centrally located marker band<br>for 1.5 configurations). The<br>catheter is compatible with 5F<br>or larger guiding catheters. The<br>internal lumen of the catheter<br>accepts a standard 0.014inch<br>PTCA guidewire. The proximal<br>part of the guidewire enters the<br>catheter tip and advances<br>coaxially out the catheter<br>proximal port, thereby allowing<br>both coaxial guidance and rapid<br>exchange of catheters with s<br>single standard length | is a polymer coated<br>stainless steel hypotube.<br>Hydrophilic lubricious<br>coatings are applied to the<br>distal section. The<br>semi-compliant balloons<br>can be inflated by injection<br>dilute contrast media<br>solution through the trailing<br>hub of the catheter. Two<br>radiopaque platinum marker<br>bands are located within the<br>balloon segment (only one<br>centrally located marker<br>band for 1.5<br>configurations). The<br>catheter is compatible with<br>5F or larger guiding<br>catheters. The internal<br>lumen of the catheter<br>accepts a standard<br>0.014inch PTCA guidewire.<br>The proximal part of the<br>guidewire enters the | The proximal shaft is a<br>PTFE coated stainless<br>steel hypotube.<br>Hydrophilic lubricious<br>coatings are applied to the<br>distal section.<br>Semi-compliant balloons<br>can be inflated by<br>injection dilute contrast<br>media solution through<br>the trailing hub of the<br>catheter Two radiopaque<br>platinum marker bands<br>are located within the<br>balloon segment (only<br>one centrally located<br>marker band for 1.0-1.5<br>configurations). The<br>catheter is compatible<br>with 4F or larger sheaths<br>or 5F or larger guiding<br>catheters. The internal<br>lumen of the catheter<br>accepts a standard | working length of 142cm.<br>The proximal shaft is<br>PTFE coated stainless<br>steel tube, which allows<br>for exceptional<br>pushability and a smooth<br>transition to the distal<br>shaft, which is composed<br>of an outer tube, an inner<br>tube, and a balloon. A<br>hydrophilic coating is<br>applied to the distal<br>section.<br>The proximal shaft of the<br>catheter has two markers<br>sections that aid in<br>gauging dilatation<br>catheter position relative<br>to the guiding catheter<br>tip). The distal shaft of the<br>catheter has an integrated<br>shaft system. The shaft<br>has a combination of<br>single lumen and dual | shaft is a PTFE coated<br>stainless steel hypotube.<br>Hydrophilic coatings<br>are applied to the distal<br>section. The<br>semi-compliant<br>balloons can be inflated<br>by injection of dilute<br>contrast media solution<br>through the hub of the<br>catheter. Two<br>radiopaque platinum<br>marker bands are<br>located within the<br>balloon segment (only<br>one centrally located<br>marker band for 1.5<br>configurations). The<br>catheter is compatible<br>with 5F or larger<br>guiding catheters. The<br>internal lumen of the<br>catheter accepts a<br>standard 0.014inch |
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601Building C, Jinweiyuan Industrial Park, Pingshan District, Shenzhen, Guangdong, CN 518118.

MEDCAPTAIN LIFE SCIENCE CO., LTD.

Tel.: [phone] Fax.: [phone]

| | guidewire. Two marked sections<br>are located on the hypotube<br>shaft to indicate catheter<br>position. The design of this<br>dilatation catheter does not<br>incorporate a lumen for distal<br>dye injections or distal pressure<br>measurements. | catheter tip and advances<br>coaxially out the catheter<br>proximal port, thereby<br>allowing both coaxial<br>guidance and rapid<br>exchange of catheters with s<br>single standard length<br>guidewire. Two marked<br>sections are located on the<br>hypotube shaft to indicate<br>catheter position. The<br>design of this dilatation<br>catheter does not<br>incorporate a lumen for<br>distal dye injections or<br>distal pressure<br>measurements. | 0.014inch guidewire. The<br>proximal part of the<br>guidewire enters the<br>catheter tip and advances<br>coaxially out the catheter<br>proximal port, thereby<br>allowing both coaxial<br>guidance and rapid<br>exchange of catheters<br>with s single standard<br>length guidewire. Two<br>marked sections are<br>located on the hypotube<br>shaft to indicate catheter<br>position. The design of<br>this dilatation catheter<br>does not incorporate a<br>lumen for distal dye<br>injections or distal<br>pressure measurements. | lumen tubing. One lumen<br>is used for inflation of the<br>balloon with contrast<br>medium. The other lumen<br>in the distal shaft permits<br>the use of a guidewire to<br>facilitate advancement of<br>the catheter. The<br>guidewire enters the<br>catheter tip and advances<br>coaxially out the distal<br>RX port. Two marker<br>bands are located within<br>the balloon segment. The<br>design of this dilatation<br>catheter does not<br>incorporate a lumen for<br>distal dye injections or<br>distal pressure<br>measurements. | PTCA guidewire. The<br>proximal part of the<br>guidewire enters the<br>catheter tip and<br>advances coaxially out<br>the catheter proximal<br>port, thereby allowing<br>both coaxial guidance<br>and rapid exchange of<br>catheters with s single<br>standard length<br>guidewire. Two marked<br>sections are located on<br>the hypotube shaft to<br>indicate catheter<br>position. The design of<br>this dilatation catheter<br>does not incorporate a<br>lumen for distal dye<br>injections or distal<br>pressure measurements. | | |
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| Prescription/<br>Over-the-Counter | Prescription | Prescription | Prescription | Prescription | Prescription | Identical | |
| Target User | Intended for use by physicians | Intended for use by | Intended for use by | Intended for use by | Intended for use by | Identical | |
| | | physicians | physicians | physicians | physicians | | |
| Access/ Anatomical site: | | Inserted percutaneously into the arterial circulation or bypass graft stenosis | Inserted percutaneously into the arterial circulation or bypass graft stenosis | Inserted percutaneously into the arterial circulation or bypass graft stenosis | Inserted percutaneously into the arterial circulation or bypass graft stenosis | Identical | |
| Use environment: | | Hospitals | Hospitals | Hospitals | Hospitals | Identical | |
| Materials: | | / | / | / | / | / | |
| Balloon material | | Pebax | Pebax | Pebax | Pebax | Identical | |
| Hypotube | | PTFE coated stainless steel | PTFE coated stainless steel | PTFE coated stainless steel | PTFE coated stainless steel | Identical | |
| Marker bands | | Platinum | Platinum | Platinum | Platinum Alloys | Identical | |
| Performance: | | / | / | / | / | / | |
| Dimensional verification | | Balloon diameter: 1.5-4.0mm | Balloon diameter: 1.5-4.0mm | Balloon diameter: 1.5-4.0mm; | Balloon diameter: 1.5-4.0mm | Identical | |
| | | Balloon length: 10-30mm | Balloon length: 10-30mm | Balloon length: 5-30mm | Balloon length: 6-30mm | Identical to Reference device 2 | |
| | | Working length: 140cm | Working length: 140cm | Working length: 140cm…