← Product Code [LIT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT) · K991540

# WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (K991540)

_AngioDynamics, Inc. · LIT · Sep 29, 1999 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT/K991540

## Device Facts

- **Applicant:** AngioDynamics, Inc.
- **Product Code:** [LIT](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/LIT.md)
- **Decision Date:** Sep 29, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1250
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

The ANGIODYNAMICS WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.

## Device Story

WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is a catheter-based device used by physicians in clinical settings to treat obstructive vascular lesions. Device is inserted percutaneously into iliac, femoral, or renal arteries, or arteriovenous dialysis fistulae. Balloon inflation facilitates dilation of stenotic vessels to improve blood flow. Device serves as a mechanical tool for angioplasty procedures; no electronic or software components involved. Benefits include restoration of vessel patency and improved hemodynamics in peripheral and dialysis access sites.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Percutaneous transluminal angioplasty balloon catheter. Mechanical device; no energy source, software, or connectivity. Materials and dimensions consistent with standard PTA catheter design for peripheral and dialysis access applications.

## 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.

## Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1999

Ms. Teri Juckett Regulatory Affairs Associate AngioDynamics® Incorporated 603 Queensbury Ave. Queensbury, NY 12804

K991540 Re:

> WorkHorse™ Percutaneous Transluminal Angioplasty Trade Name: Balloon Catheter Regulatory Class: II Product Code: LIT Dated: July 26, 1999 Received: July 28, 1999

Dear Ms. Juckett:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 Regulations, 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 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 Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have

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Page 2 - Ms. Terry Juckett

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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation 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 (800) 638-2041 or (301) 443-6597 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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## INDICATIONS FOR USE

510(k) Application: New Application

Device Name: WorkHorse™ Percutaneous Transluminal Angioplasty Balloon

Indications for Use:

The ANGIODYNAMICS WorkHorse™ Percutaneous Transluminal Angioplasty Balloon is indicated for general Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. These catheters are not designed to be used in the coronary arteries.

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Device

Oli-to/sm/Ahr-for Callahan

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

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