VASCON POLARIS GUIDING CATHETER

K033633 · Vascon, LLC · DQY · Feb 18, 2004 · Cardiovascular

Device Facts

• Record ID: K033633
• Device Name: VASCON POLARIS GUIDING CATHETER
• Applicant: Vascon, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 18, 2004
• 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

VasCon Polaris Guiding Catheter is a single-lumen catheter used for intravascular delivery of interventional or diagnostic devices into coronary or peripheral vascular systems. Device features nylon body reinforced with stainless steel wire braid, PTFE lubricious inner lumen, and soft radiopaque tip to minimize vessel injury. Available in 5Fr, 6Fr, 7Fr, and 8Fr sizes, 100 cm length, and various shapes. Used by clinicians in clinical settings to facilitate access for other devices. Benefits include improved navigation and reduced trauma during vascular procedures.

Clinical Evidence

No clinical data. Bench testing only, including performance specification testing and biocompatibility testing.

Technological Characteristics

Single lumen catheter; nylon body with stainless steel wire braid reinforcement; PTFE lubricious inner lumen; soft radiopaque tip. Sizes: 5Fr, 6Fr, 7Fr, 8Fr; 100 cm length. Various shapes available.

Indications for Use

Indicated for 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

• Cordis Guiding Catheters (Vista BRITE TIP®)

Submission Summary (Full Text)

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K033633

## FEB 1 8 2004

## 510(k) SUMMARY

| Submitter's<br>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 | 18 November 2003 |
| Name of Device | Common Name: Guiding Catheter<br>Classification Name: Percutaneous Catheter<br>Trade Name: VasCon Polaris™ Guiding Catheter |
| Predicate Device | Cordis Guiding Catheters (Vista BRITE TIP®) |
| 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<br>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<br>Summary | Laboratory testing has been performed on the VasCon Polaris™<br>Guiding Catheters to assure compliance to the specifications.<br>In addition, laboratory testing has been performed on the materials<br>to assure biocompatibility. |
| Conclusions | The testing as discussed above demonstrate that, like the predicate<br>devices, the VasCon Polaris™ Guiding Catheters are safe and<br>effective for its intended use. |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 2004

VasCon LLC c/o Stephen P. Vadas, Ph.D. Vice President, Product Assurance & Regulatory Affairs 9344 NW 13th Street Miami, FL 33172

Re: K033633

Trade Name: VasCon Polaris Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutancous Regulatory Class: Class II (two) Product Code: DQY Dated: November18, 2003 Received: November 19, 2003

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.

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

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 that I Dri has made a aoth regulations administered by other Federal agencies. You must or any I cach stututed and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. [rouder latiation control pro herens (evens (evens (evice as described in your Section 510(k) I his icher will anow you to begin manusing of substantial equivalence of your device to a legally premarket notification: "The PDF 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 if you desire spicente 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 other general mionnation and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. Vochner

Bram D. Zuckerman, M.D. 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): K033633 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VasCon Polaris™ Guiding Catheter |
| Indications For Use: | The guiding catheter is intended for use for intravascular<br>introduction of interventional / diagnostic devices into the<br>coronary or peripheral vascular systems. |

× Prescription Use _ (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)

Duuna R. bochner

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(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K033633

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