VASCON POLARIS GUIDING CATHETER

K043387 · Vascon, LLC · DQY · Feb 16, 2005 · Cardiovascular

Device Facts

• Record ID: K043387
• Device Name: VASCON POLARIS GUIDING CATHETER
• Applicant: Vascon, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.

Device Story

The VasCon Polaris™ Guiding Catheter is a single-lumen catheter used by clinicians to facilitate the delivery of interventional or diagnostic devices into coronary or peripheral vascular systems. The device features a nylon body reinforced with stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip designed to minimize vessel trauma. It is available in various French sizes (5Fr, 6Fr, 7Fr, 8Fr), a standard 100 cm length, and multiple tip shapes to accommodate different anatomical requirements. The catheter is used in clinical settings during vascular procedures; it acts as a conduit for other devices, allowing healthcare providers to navigate and position diagnostic or therapeutic tools within the vasculature. By providing a stable pathway, the device assists in the successful execution of minimally invasive cardiovascular interventions, potentially improving patient outcomes during diagnostic or interventional procedures.

Clinical Evidence

Bench testing only. Laboratory testing was performed to ensure compliance with device specifications and to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Single-lumen catheter; nylon body with stainless steel wire braid reinforcement; PTFE lubricious inner lumen; soft radiopaque tip. Available in 5Fr, 6Fr, 7Fr, and 8Fr sizes; 100 cm length; various shapes. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional or diagnostic devices into the coronary or peripheral vascular systems.

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

• VasCon Polaris™ Guiding Catheters (K033633)

Submission Summary (Full Text)

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FEB 1 6 2005

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## 510(k) SUMMARY

| Submitter's Information | VasCon LLC<br>9344 NW 13 Street<br>Miami, Florida 33172 USA<br>Telephone: [phone]<br>Fax: [phone]<br>Contact: Stephen F. Vadas, Ph.D. |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | 08 December 2004 |
| Name of Device | Common Name: Guiding Catheter<br>Classification Name: Percutaneous Catheter<br>Trade Name: VasCon Polaris™ Guiding Catheter |
| Predicate Device | VasCon Polaris™ Guiding Catheters, 510(k) K033633 |
| Intended Use | The guiding catheter is intended for use for intravascular introduction<br>of interventional / diagnostic devices into the coronary or peripheral<br>vascular systems. |
| Device Description and<br>Summary of<br>Technological<br>Characteristics | The VasCon Polaris™ Guiding Catheters are single lumen<br>catheters, incorporating a nylon body reinforced with a stainless<br>steel wire braid, a PTFE lubricious inner lumen, and a soft<br>radiopaque tip to reduce potential vessel injury. They are available in<br>5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes.<br>The technological characteristics are equivalent to the predicate<br>device. |
| Testing Summary | Laboratory testing has been performed on the VasCon Polaris™<br>Guiding Catheters to assure compliance to the specifications. |
| Conclusions | The testing as discussed above demonstrate that, like the predicate<br>device, the VasCon Polaris™ Guiding Catheters are safe and<br>effective for its intended use. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2005

Stephen F. Vadas, Ph.D., P.E. Vice President, Product Assurance and Regulatory Affairs VasCon LLC 9344 NW 13 Street Miami, FL 33172

K043387 Re:

Trade/Device Name: VasCon Polaris™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: December 8, 2004 Received: December 9, 2004

Dear Dr. Vadas:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Stephen F. Vadas, Ph.D., P.E.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lokel with and in the FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dana R. Lachner

Bram D. Zuckerman, M.D. SD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ¥043387

VasCon Polaris™ Guiding Catheter Device Name: The guiding catheter is intended for use for Indications For Use: intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

DIANNA R. Ladner

(Divisi 1 Sign-Off) (Division of Cardiovascular Devices

16111 Number_K043383

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