URESIL VASCU-FLO INFUSION CATHETER

K980278 · Uresil Corp. · DQY · Nov 20, 1998 · Cardiovascular

Device Facts

• Record ID: K980278
• Device Name: URESIL VASCU-FLO INFUSION CATHETER
• Applicant: Uresil Corp.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to infuse therapeutic agents into the extra-cardiac vasculature.

Device Story

The Uresil VASCU-FLO Infusion Catheter is a medical device designed for the delivery of therapeutic agents directly into the extra-cardiac vasculature. It is intended for use by clinicians in a hospital or clinical setting. The device functions as a conduit for fluid administration, allowing for targeted delivery of medications. By facilitating precise infusion, the catheter assists healthcare providers in managing patient conditions requiring localized vascular therapy. The device is operated by trained medical professionals.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion catheter for extra-cardiac vascular access. Design and materials are consistent with standard infusion catheter technology for vascular applications.

Indications for Use

Indicated for patients requiring infusion of therapeutic agents into the extra-cardiac vasculature.

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.

Submission Summary (Full Text)

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Food and Drug Administration Rockville MD 20857

NOV 20 1998

Mr. Matthew Curtis, CQE Quality Assurance and Regulatory Affairs Manager Uresil Technology Center 5418 West Toughy Avenue Skokie, IL 60077

K980278 Re: Uresil® VASCU-FLO® Infusion Catheter Trade Name: Requlatory Class: II Product Code: DQY Dated: Auqust 28, 1998 Received: September 1, 1998

Dear Mr. Curtis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Curtis Matthew

you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): unknown

Device Name: Uresil® VASCU-FLO® Infusion Catheter

Indications For Use:

This device is intended to infuse therapeutic agents into the extra-cardiac vasculature.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use
(Optional Format 1-2-96)

*D. Gatt* for *TJ Callahan*
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K986278