CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER

K993720 · Cordis Corp. · KNQ · Jan 18, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993720
• Device Name: CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
• Applicant: Cordis Corp.
• Product Code: KNQ · Gastroenterology, Urology
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5365
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter is for the dilatation of strictures of the esophagus.

Device Story

Over-the-wire balloon dilatation catheter; features distal balloon and proximal hub; includes two radiopaque marker bands. Used by clinicians for esophageal stricture dilatation. Device functions via mechanical inflation of balloon to expand strictured tissue. Biocompatible materials used throughout construction.

Clinical Evidence

Bench testing only.

Technological Characteristics

Over-the-wire balloon catheter; distal balloon; proximal hub; two radiopaque marker bands; biocompatible materials.

Indications for Use

Indicated for the dilatation of esophageal strictures in patients requiring such intervention.

Regulatory Classification

Identification

An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Cordis Maxi LD PTA Balloon Catheter
• Boston Scientific XXL Balloon Dilatation Catheter

Submission Summary (Full Text)

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## K993720

## JAN 1 8 2000

## Summary of Safety and Effectiveness

General Provisions

The name of the device is:

| Proprietary Name | Common or Usual Name |
|-----------------------------------------------------------|----------------------|
| Cordis Maxi LD Large Diameter Balloon Dilatation Catheter | Esophageal Dilator |

Name of Predicate Devices

The device is substantially equivalent to:

- Cordis Maxi LD PTA Balloon Catheter
- Boston Scientific XXL Balloon Dilatation Catheter

| Classification | Class II. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. |
| Indications for Use | The intended use of the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter is for the dilatation of strictures of the esophagus. |
| Device Description | The device is an over the wire balloon catheter, with a distal balloon and a proximal hub. The balloon features two radiopaque marker bands. |
| Biocompatibility | All materials used in the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter are biocompatible. |
| Summary of Substantial Equivalence | The Cordis Maxi LD Large Diameter Balloon Dilatation Catheter is substantially equivalent to the predicate devices. The equivalence was confirmed through pre-clinical testing. |

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JAN 1 8 2000

Ms. Ariel MacTavish, RAC Manager Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K993720

Cordis Maxi LD Large Diameter Balloon Dilatation Catheter for the Esophaqus Dated: November 1, 1999 Received: November 3, 1999 Regulatory Class: II 21 CFR §876.5365/Procode: 78 KNQ

Dear Ms. MacTavish:

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). 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 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 regulations.

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"(21 CFR 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number<br>(if known) | K993720 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter |
| Indications for<br>Use | The intended use of the Cordis Maxi LD Large Balloon Dilatation<br>Catheter is for the dilatation of strictures of the esophagus. |

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |

510(k) Number K993720

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Cordis Maxi LD Large Diameter Balloon Dilatation Catheter November, 1999