MAXI LD PTA BALLOON CATHETER

K963000 · Cordis Corp. · LIT · Feb 20, 1997 · Cardiovascular

Device Facts

• Record ID: K963000
• Device Name: MAXI LD PTA BALLOON CATHETER
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Feb 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maxi PTA catheter is intended to dilate lesions in large vessels.

Device Story

Over-the-wire balloon catheter; distal balloon; proximal hub; two radiopaque marker bands. Used by physicians in clinical settings for percutaneous transluminal angioplasty (PTA) to dilate stenotic lesions in large vessels. Device facilitates vessel patency by mechanical inflation of balloon at lesion site.

Clinical Evidence

Bench testing only. In vitro tests performed to ensure safety and effectiveness; all results met or exceeded specifications.

Technological Characteristics

Over-the-wire balloon catheter; radiopaque marker bands; materials passed biocompatibility testing.

Indications for Use

Indicated for the dilation of stenotic lesions in large vessels.

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.

Predicate Devices

• Cordis Opta 5 PTA Balloon Catheter
• Cordis Powerflex 5F PTA Balloon Catheter
• Cook Omega N.V. Balloon Dilatation Catheter

Submission Summary (Full Text)

{0}

07-00032
K963000

# Section 513(j) of the Federal Food, Drug and Cosmetic Act
## Summary of Safety and Effectiveness

July 26, 1996
FEB 20 1997

## I. General Provisions

Common or Usual name: PTA Balloon Catheter

Proprietary name: Cordis Maxi PTA Balloon Catheter

Name and Address of Applicant: Cordis Corporation
Miami Lakes Operation Center
14201 NW 60 Avenue
Miami Lakes, FL 33014

## II. Name of Predicate Devices

Cordis Opta 5 PTA Balloon Catheter
Cordis Powerflex 5F PTA Balloon Catheter
Cook Omega N.V. Balloon Dilatation Catheter

## III. Classification

PTA catheters are class II devices according to 21 CFR 870.1340.

## IV. Performance Standards

Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description

The Maxi PTA catheter is intended to dilate lesions in large vessels. The device is an over-the-wire balloon catheter, with a distal balloon and a proximal hub. The balloon is indicated by two radiopaque marker bands.

## VI. Biocompatibility

All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Maxi PTA Catheter.

## VII. In vitro Testing

{1}

00-00033

A series of in vitro tests were performed to assure that the introduction of the Maxi PTA catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications.

## VIII. Summary of Substantial Equivalence

The Maxi PTA catheter is designed for dilatation of stenotic lesions in large vessels. The Maxi PTA catheters have the same intended use, and several of the same materials, design characteristics and dimensions as the predicate devices.