VASCON NEUROPATH GUIDING CATHETER

K052004 · Vascon, LLC · DQY · Jan 19, 2006 · Cardiovascular

Device Facts

• Record ID: K052004
• Device Name: VASCON NEUROPATH GUIDING CATHETER
• Applicant: Vascon, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.

Device Story

Single lumen guiding catheter; used for intravascular introduction of interventional or diagnostic devices into coronary, peripheral, and neurovasculature. Device features PEBAX body with stainless steel wire braid; intermediate segment includes stainless steel coil for kink resistance and torque response; radiopaque 35D PEBAX tip to minimize vessel injury. Available in 5Fr and 6Fr sizes, 90 and 100 cm lengths, and various shapes. Operated by physicians in clinical settings to facilitate access for secondary interventional tools.

Clinical Evidence

Bench testing only. Mechanical laboratory testing performed to verify specifications; biocompatibility testing performed on materials.

Technological Characteristics

Single lumen catheter; PEBAX body with stainless steel wire braid reinforcement; intermediate segment with stainless steel coil; radiopaque 35D PEBAX tip. Available in 5Fr and 6Fr diameters, 90 and 100 cm lengths. Non-active device.

Indications for Use

Indicated for use in coronary, peripheral, and neurovasculature for the intravascular introduction of interventional or diagnostic devices.

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 Catheter (ENVOY® series)
• VasCon Guiding Catheter (Polaris™)

Submission Summary (Full Text)

{0}------------------------------------------------

JAN 1 9 2006

## 510(k) SUMMARY

K052004

| Submitter's<br>Information | VasCon LLC<br>9344 NW 13 Street<br>Miami, Florida 33172 USA<br>Telephone: [phone]<br>Contact: Stephen F. Vadas, Ph.D. |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | July 6, 2005 |
| Name of Device | Common Name: Guiding Catheter<br>Classification Name: Percutaneous Catheter<br>Trade Name: VasCon NeuroPath™ Guiding Catheter |
| Predicate Devices | Cordis Guiding Catheter (ENVOY® series)<br>VasCon Guiding Catheter (Polaris™) |
| Intended Use | VasCon NeuroPath™ Guiding Catheter is intended for use in the<br>coronary, peripheral, and neurovasculature for intravascular<br>introduction of interventional/diagnostic devices. |
| Device Description<br>and Summary of<br>Technological<br>Characteristics | The VasCon NeuroPath™ Guiding Catheter is a single lumen<br>catheter, incorporating a PEBAX® body reinforced with a stainless<br>steel wire braid. The intermediate segment is also PEBAX® with a<br>stainless steel coil to reduce kinking and to promote improved<br>torque response. The tip is composed of radiopaque 35D PEBAX®<br>to reduce potential vessel injury. They are available in 5Fr and<br>6Fr, 90 and 100 cm in length, and in a variety of shapes. The<br>technological characteristics are equivalent to the predicate<br>devices. |
| Testing Summary | Mechanical laboratory testing has been performed on the VasCon<br>NeuroPath™ Guiding Catheter to assure compliance to the<br>specifications. In addition, testing has been performed on the<br>materials to assure biocompatibility. |
| Conclusions | The non-clinical tests as discussed above demonstrate that, like the<br>predicate devices, the VasCon NeuroPath™ Guiding Catheter is<br>safe and effective for its intended use. |

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

VasCon LLC c/o Stephen F. Vadas, Ph.D. Vice President, Product Assurance & Regulatory Affairs 9344 N.W. 13 Street, Suite 200 Miami, FL 33172

K052004 Re: VasCon NeuroPath™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II Product Code: DQY Dated: December 27, 2005 Received: December 29, 2005

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.

{2}------------------------------------------------

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be actived 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 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) remarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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 Mace gacturers, 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,

R. Wehner

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

Enclosure

{3}------------------------------------------------

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: VasCon NeuroPath™ Guiding Catheter

Indications for Use:

VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.

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

Over-The-Counter Use (Part 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)

Duna R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) number K052004