MEGA PTA BALLOON CATHETER

K955886 · Cordis Corp. · LIT · Mar 11, 1996 · Cardiovascular

Device Facts

• Record ID: K955886
• Device Name: MEGA PTA BALLOON CATHETER
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis Mega PTA Balloon Catheters are designed for dilatation of stenotic lesions within the peripheral vessels.

Device Story

Percutaneous transluminal angioplasty (PTA) balloon catheter; coaxial design (tube-within-a-tube); distal balloon; proximal Y-shaped hub with dual lumens. Inner lumen for guidewire (max 0.018") and contrast/saline injection; outer lumen for balloon inflation/deflation. Two radiopaque marker bands for positioning. Used by physicians in clinical settings for peripheral vessel stenosis dilatation. Device facilitates vessel opening via balloon expansion.

Clinical Evidence

Bench testing only; biocompatibility testing performed per Tripartite Guidance Document.

Technological Characteristics

Coaxial catheter design; dual-lumen; radiopaque marker bands; materials passed Tripartite Guidance biocompatibility testing. No electronic or software components.

Indications for Use

Indicated for dilatation of stenotic lesions within peripheral 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 Savvy PTA Balloon Catheter
• Cordis Opta 5 PTA Balloon Catheter
• Cordis Small Vessel PTA Balloon Catheter
• Schneider SofTrac

Submission Summary (Full Text)

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27DEC.95

# Summary of Substantial Equivalence

## Section 513(i) of the Federal, Drug and Cosmetic Act

December 1995

## I. General Provisions

**Classification Name**

None established

**Common/Usual Name**

Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

**Proprietary Name**

Cordis Mega PTA Balloon Catheter

## II. Name and Address of Applicant

Cordis Corporation
P.O. Box 025700
Miami, FL 33102-5700

Contact Name:

*Martine D. Schneider*
Martine D. Schneider, Regulatory and Clinical Affairs

## III. Name of Predicate Devices

Cordis Savvy PTA Balloon Catheter
Cordis Opta 5 PTA Balloon Catheter
Cordis Small Vessel PTA Balloon Catheter
Schneider SofTrac

## IV. Classification

PTA Balloon Catheters are classified as class II devices.

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00-00211

## V. Performance Standards

Performance standards for PTA Balloon Catheters have not been established under Section 514 of the Food, Drug and Cosmetic Act.

## VI. Intended Use and Product Description

The Cordis Mega PTA Balloon Catheters are designed for dilatation of stenotic lesions within the peripheral vessels. Mega catheters have a coaxial design (tube within a tube) with a balloon on the distal tip. Two (2) lumens, an inner and outer lumen, are split on the proximal end by a Y-shaped one piece hub. The inner lumen (denoted by "thru") molded into the hub) is used for contrast medium or saline injections and guidewire insertion (maximum guidewire diameter is 0.018"). The outer lumen (denoted by "balloon" molded into the hub) is used for inflation and deflation of the balloon. Two (2) radiopaque marker bands placed within the balloon working length aid the physician in proper balloon placement.

## VII. Biocompatibility

All appropriate biocompatibility tests were performed and successfully passed on the materials used in the Mega PTA Balloon Catheter, as specified in the Tripartite Guidance Document.

## VIII. Summary of Substantial Equivalence

The Cordis Mega Percutaneous Transluminal Angioplasty (PTA) Balloon catheters are designed for dilatation of stenotic lesions within peripheral vessels. Mega catheters have the same intended use and several of the same materials, design characteristics and dimensions as other currently marketed devices and the previously concurred Savvy catheters. Physical testing of the Mega PTA Balloon Catheters demonstrates equivalent performance to previously and existing PTA catheter designs.

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