← Product Code [LIT](/productcode/LIT) · K962945

# CORDIS OPTA PTA BALLOON CATHETER (K962945)

_Cordis Corp. · LIT · Oct 23, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K962945

## Device Facts

- **Applicant:** Cordis Corp.
- **Product Code:** [LIT](/productcode/LIT.md)
- **Decision Date:** Oct 23, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1250
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

The Cordis Opta 5™ PTA Balloon Catheter is intended to dilate stenoses in peripheral arteries and is applied to the iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries.

## Device Story

Coaxial PTA balloon catheter; distal inflatable balloon; radiopaque marker bands for placement; tapered tip for stenosis crossing. Used in peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal). Operated by physicians; contrast medium delivered via 10-cc syringe (hand injection, 150 psi max); inflation/deflation via inflation lumen; tracks over guidewire. Benefits: mechanical dilation of arterial stenoses to improve blood flow.

## Clinical Evidence

Bench testing only. No clinical data provided.

## Technological Characteristics

Coaxial catheter design; distal inflatable balloon; radiopaque marker bands; tapered tip. Materials are biocompatible. Nominal pressure 3-6 atm depending on diameter; rated burst pressure specified. Manual inflation/deflation via inflation lumen; contrast delivery via injectate lumen. No software or electronic components.

## 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.

## Predicate Devices

- Cordis Opta 5™ PTA Balloon Catheter ([K962945](/device/K962945.md))
- Cordis Mega PTA Balloon Catheter
- Meditech Ultra-Thin™/Blue Max Balloon Catheter
- Cook Accent® Balloon Angioplasty Catheter

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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SUMMARY OF SAFETY AND EFFECTIVENESS

OCT 23 1996
K962945

I. General Provisions

Common or Usual Name: PTA Balloon Catheter

Proprietary Name: Opta 5™ PTA Balloon Catheter

II. Name of Predicate Devices

Cordis Opta 5™ PTA Balloon Catheter
Cordis Mega PTA Balloon Catheter
Meditech Ultra-Thin™/Blue Max Balloon Catheter
Cook Accent® Balloon Angioplasty Catheter

III. Classification

Class II

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 Cordis Opta 5™ PTA Balloon Catheter is intended to dilate stenoses in peripheral arteries and is applied to the iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries.

The Cordis Opta 5™ PTA Balloon Catheter is a coaxial design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.

The recommended working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. 3mm through 10mm diameter balloons reach their nominal size between 5 and 6 atm internal pressure. The 12mm diameter balloons reaches its nominal size between 3 and 4 atm internal pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal size pressure range.

The injectate lumen is used to deliver contrast medium by using a 10-cc syringe, hand injection only (150 psi maximum), and to track the catheter over a prepositioned guidewire. The compatible guidewire size, catheter shaft French size and catheter length are printed on the injectate lumen hub.

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The inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the balloon lumen hub.

## VI. Biocompatibility

All materials used in the Opta 5™ PTA balloon catheter are biocompatible.

## VII. Summary of Substantial Equivalence

The Cordis Opta 5™ PTA Balloon Catheter and the referenced current Cordis Opta 5™ PTA Balloon Catheter, Cordis Mega PTA Balloon Catheter, Meditech Ultra-Thin™/Blue Max Balloon Catheter and Cook Accent® Balloon Angioplasty Catheter are similar in their basic design, construction, indication for use and performance characteristics.

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**Source:** [https://fda-staging.innolitics.com/device/K962945](https://fda-staging.innolitics.com/device/K962945)

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