ASCEND BALLOON DAILATION CATHETER

K970041 · Cook Urological, Inc. · EZN · Mar 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970041
• Device Name: ASCEND BALLOON DAILATION CATHETER
• Applicant: Cook Urological, Inc.
• Product Code: EZN · Gastroenterology, Urology
• Decision Date: Mar 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter.

Device Story

Ascend™ Balloon Dilation Catheter; used for ureteral dilation; facilitates ureteral stone manipulation or ureteroscopy; dilates intramural ureter. Device consists of 7 FR diameter catheter, 40cm-65cm length, with 5mm-10mm x 4cm-12cm balloon. Operated by urologists in clinical settings. Provides mechanical dilation of ureteral structures to improve access for subsequent procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: urethane and polyethylene. Dimensions: 7 FR diameter, 40-65cm length, 5-10mm x 4-12cm balloon. Mechanical dilation principle. Sterilization via standard procedures.

Indications for Use

Indicated for patients requiring ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and for dilation of the intramural ureter.

Regulatory Classification

Identification

A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.

Predicate Devices

• Balloon Dilation Catheters (Bard)
• High Pressure Ureteral Dilatation Balloon Catheter (Microvasive)

Submission Summary (Full Text)

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K970041
MAR 19 1997
9

510(k) Premarket Notification
Ascend™ Balloon Dilation Catheter
Cook Urological

## L 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### Submitted By:

Tammy Bacon
Cook Urological
1100 West Morgan Street
Spencer, Indiana 47460
[phone]
January 3, 1997

### Device

Trade Name: Ascend™ Balloon Dilation Catheter
Proposed Classification Name: Dilator, Catheter, Ureteral

### Predicate Devices:

The Ascend™ Balloon Dilation Catheter is substantially equivalent to predicate devices in terms of indications for use and design. Predicate devices include Balloon Dilation Catheters manufactured by Bard and High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive.

### Device Description:

The Ascend™ Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon are urethane and polyethylene. The Ascend™ Balloon Dilation Catheter will be offered in a 7 FR diameter and 40cm to 65cm long catheter with a 5mm to 10mm x 4cm to 12cm balloon.

### Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.