VASCON ROAMER MICROCATHETER

K053310 · Vascon, LLC · KRA · Jul 3, 2008 · Cardiovascular

Device Facts

• Record ID: K053310
• Device Name: VASCON ROAMER MICROCATHETER
• Applicant: Vascon, LLC
• Product Code: KRA · Cardiovascular
• Decision Date: Jul 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.

Device Story

VasCon Roamer Microcatheter is a single-lumen catheter designed for selective infusion of diagnostic, therapeutic, and embolic agents into peripheral, coronary, and neurovasculature. Device features Pebax body reinforced with stainless steel and platinum wire, PTFE inner lumen, and soft radiopaque tip to minimize vessel trauma. Hydrophilic coating enhances lubricity. Used by clinicians in interventional procedures to deliver agents to target sites. Benefits include precise agent delivery and reduced risk of vessel injury during navigation.

Clinical Evidence

Bench testing only. Laboratory testing performed to verify compliance with specifications and biocompatibility requirements.

Technological Characteristics

Single lumen catheter; Pebax body reinforced with stainless steel and platinum wire; PTFE inner lumen; soft radiopaque tip; hydrophilic coating. Available in French sizes 2.3/1.9 to 2.8/2.7; lengths 105-150 cm; ID 0.017-0.027 inches.

Indications for Use

Indicated for selective infusion of diagnostic, therapeutic, and embolic agents into peripheral, coronary, and neurovasculature.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Cordis Catheters (MassTransit®, Prowler® Plus, and the Prowler® 14)

Submission Summary (Full Text)

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## KD 53210

## 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.<br>JUL - 3 2008 |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date | 18 November 2005 |
| Name of Device | Classification Name: Continuous Flush Catheter<br>Trade Name: VasCon Roamer Microcatheter |
| Predicate Device | Cordis Catheters (MassTransit®, Prowler® Plus, and the Prowler® 14) |
| Intended Use | The VasCon Roamer Microcatheters are indicated for the selective<br>infusion of various diagnostic, therapeutic, and embolic agents into the<br>peripheral, coronary, and neurovasculature. |
| Device<br>Description and<br>Summary of<br>Technological<br>Characteristics | The VasCon Roamer Microcatheters are single lumen catheters,<br>incorporating a Pebax body reinforced with stainless steel and<br>platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque<br>tip to reduce potential vessel injury. They are available in French sizes<br>of 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105<br>cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019,<br>0.021, and 0.027 inches. They have a hydrophilic coating to provide<br>lubricity during use. The technological characteristics are equivalent to<br>the predicate device. |
| Testing<br>Summary | Laboratory testing has been performed on the VasCon Roamer<br>Microcatheter to assure compliance to the specifications.<br>In addition, laboratory testing has been performed on the materials to<br>assure biocompatibility. |
| Conclusions | The testing as discussed above demonstrates that, like the predicate<br>devices, the VasCon Roamer Microcatheters are safe and effective for<br>its intended use. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VasCon LLC c/o Stephen F. Vadas, PhD Vice President 9344 NW 13th Street Miami, FL 33172

Re: K053310

> Trade/Device Name: VasCon Roamer Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: catheter, continuous flush Regulatory Class: Class II Product Code: KRA Dated: March 12, 2008 Received: April 7, 2008

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 he 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 - Dr. Stephen F. Vadas

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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) premarket notification. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Anrley B. Boan

for

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

Enclosure

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Indications for Usc

510(k) Number (if known):

K053310

VasCon Roamer Microcatheter Device Name:

## Indications For Use:

The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.

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)

Andree Brown for BDZ