URESIL DILATOR WITH RADIOPAQUE MARKER

K980282 · Uresil Corp. · DRE · Apr 24, 1998 · Cardiovascular

Device Facts

• Record ID: K980282
• Device Name: URESIL DILATOR WITH RADIOPAQUE MARKER
• Applicant: Uresil Corp.
• Product Code: DRE · Cardiovascular
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1310
• Device Class: Class 2

Intended Use

This device is intended to help create a tract for catheter insertion.

Device Story

UreSil Dilator with Radiopaque Marker is a medical device used to facilitate the creation of a tract for subsequent catheter insertion. The device features a radiopaque marker to assist in visualization during placement. It is intended for use by clinicians in a medical setting. By creating a stable tract, the dilator aids in the accurate and safe placement of catheters, potentially reducing procedural complications and improving patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a dilator equipped with a radiopaque marker for visualization under imaging. It is classified as a Class II device (Product Code: DRE).

Indications for Use

Indicated for patients requiring the creation of a tract for catheter insertion.

Regulatory Classification

Identification

A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle's head and three waves, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 4 1998

Mr. Lev Melinyshyn Director of Operations UreSil® Technoloqy Center 5418 W. Touhy Avenue Skokie, IL 60077

Re: K980282 Trade Name: UreSil Dilator with Radiopaque Marker Regulatory Class: II Product Code: DRE Dated: January 20, 1998 Received: January 26, 1998

Dear Mr. Melinyshyn:

We have reviewed your Secţion 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, Drug, 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 895. A substantially equivalent determination assumes compliance with 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 Drug 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

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

Page 2 - Mr. Melinyshyn

obligation 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]. 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".

ﻓﻴﻬ

. Sincerely yours,

Thomas J. Callahan

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

Enclosure

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

## ATTACHMENT C

Page 1 of 1

510(k) Number (if known): unknown

Device Name: Uresil® Dilator with Radiopaque Marker

Indications For Use:

This device is intended to help create a tract for catheter insertion.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nh. P

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

Neurological Devices
510(k) Number K980282

Prescription Use (Per 21 CFR 801.109)

OR

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

f/n: intenus