CORDIS OPTA5 PTA BALLOON CATHETER

K970620 · Cordis Corp. · LIT · May 6, 1997 · Cardiovascular

Device Facts

• Record ID: K970620
• Device Name: CORDIS OPTA5 PTA BALLOON CATHETER
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: May 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae

Device Story

Coaxial PTA balloon catheter; distal inflatable balloon; two radiopaque marker bands for placement; balloon lumen for inflation/deflation; injectate lumen for guidewire tracking or contrast/saline injection. Used by physicians in clinical settings for percutaneous transluminal angioplasty. Device tracks over prepositioned guidewire; balloon inflated to dilate stenoses; radiopaque markers aid visualization under fluoroscopy. Benefits include restoration of blood flow in peripheral arteries and dialysis fistulae.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Coaxial catheter design; distal inflatable balloon; radiopaque marker bands; injectate lumen (max 500 psi); biocompatible materials. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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 Opta5 PTA Balloon Catheter
• Cordis Nylex Angiographic Catheter
• Cordis Ducor PTA Catheter
• Meditech Ultra-Thin Balloon Catheter

Submission Summary (Full Text)

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K970620

# SUMMARY OF SAFETY EFFECTIVENESS

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## I. General Provisions

May 6 1997

Common or Usual Name: PTA Balloon Catheter

Proprietary Name: Opta5™ PTA Balloon Catheter

## II. Name of Predicate Devices

- Cordis Opta5 PTA Balloon Catheter
- Cordis Nylex Angiographic Catheter
- Cordis Ducor PTA Catheter
- Meditech Ultra-Thin Balloon 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 Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae

The Cordis Opta5 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 working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure.

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

The injectate lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 500 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon. The tip length of the long tip version is approximately 10cm and is provided with side holes.

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# VI. Biocompatibility

All materials used in the Opta5 PTA balloon catheter are biocompatible.

# VII. Summary of Substantial Equivalence

The Cordis Opta5 PTA balloon catheter and the referenced current Cordis Opta5 PTA balloon catheter, Cordis Ducor PTA catheter, Cordis Nylex angiographic catheter and Meditech Ultra-Thin balloon catheter are similar in their basic design, construction, indication for use and performance characteristics.