← Product Code [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY) · K052004 # VASCON NEUROPATH GUIDING CATHETER (K052004) _Vascon, LLC · DQY · Jan 19, 2006 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K052004 ## Device Facts - **Applicant:** Vascon, LLC - **Product Code:** [DQY](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY.md) - **Decision Date:** Jan 19, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1250 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ JAN 1 9 2006 ## 510(k) SUMMARY K052004 | Submitter's
Information | VasCon LLC
9344 NW 13 Street
Miami, Florida 33172 USA
Telephone: 1-305-477-2406
Contact: Stephen F. Vadas, Ph.D. | |--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Preparation Date | July 6, 2005 | | Name of Device | Common Name: Guiding Catheter
Classification Name: Percutaneous Catheter
Trade Name: VasCon NeuroPath™ Guiding Catheter | | Predicate Devices | Cordis Guiding Catheter (ENVOY® series)
VasCon Guiding Catheter (Polaris™) | | Intended Use | VasCon NeuroPath™ Guiding Catheter is intended for use in the
coronary, peripheral, and neurovasculature for intravascular
introduction of interventional/diagnostic devices. | | Device Description
and Summary of
Technological
Characteristics | The VasCon NeuroPath™ Guiding Catheter is a single lumen
catheter, incorporating a PEBAX® body reinforced with a stainless
steel wire braid. The intermediate segment is also PEBAX® with a
stainless steel coil to reduce kinking and to promote improved
torque response. The tip is composed of radiopaque 35D PEBAX®
to reduce potential vessel injury. They are available in 5Fr and
6Fr, 90 and 100 cm in length, and in a variety of shapes. The
technological characteristics are equivalent to the predicate
devices. | | Testing Summary | Mechanical laboratory testing has been performed on the VasCon
NeuroPath™ Guiding Catheter to assure compliance to the
specifications. In addition, testing has been performed on the
materials to assure biocompatibility. | | Conclusions | The non-clinical tests as discussed above demonstrate that, like the
predicate devices, the VasCon NeuroPath™ Guiding Catheter is
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K052004](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQY/K052004) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com