DILATION CATHETER, BALLOON

K965067 · Boston Scientific Corp · GBM · Jan 28, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K965067
• Device Name: DILATION CATHETER, BALLOON
• Applicant: Boston Scientific Corp
• Product Code: GBM · Gastroenterology, Urology
• Decision Date: Jan 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UDB Catheter is intended to dilate constricted areas of the urethra, prostatic urethra and ureters.

Device Story

UDB Catheter; over-the-wire or non-over-the-wire balloon dilatation catheter. Features two-lumen shaft, molded bifurcation, dilatation balloon, Coudé tip. Includes 10 cc luer lock syringe. Used by clinicians to dilate constricted urethral, prostatic urethral, and ureteral passages. Mechanical operation via balloon inflation to restore patency in constricted anatomical structures.

Clinical Evidence

Bench testing only; performance characteristics compared to predicate devices.

Technological Characteristics

Two-lumen catheter shaft, molded bifurcation, dilatation balloon, Coudé tip. Includes 10 cc luer lock syringe. Mechanical dilatation principle.

Indications for Use

Indicated for patients requiring dilation of constricted areas of the urethra, prostatic urethra, and ureters.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Submission Summary (Full Text)

{0}

JAN 28 1997
K965067
p1072

# 510 (k) Summary Of Safety And Effectiveness

Sponsor: Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537

Contact Person: Carol J. Holloway
Regulatory Affairs Specialist

Submission Date: December 13, 1996

Common/Usual Names: Dilatation Catheter, Balloon

Trade/Proprietary Name: TBD

Classification Name: Boston Scientific Corporation believes the proposed device can be described by the following device classification names:
- Dilator, Catheter, Ureteral (78 EZN)
- Catheter, Urethral Dilator (78 KOE)
- Catheter, Balloon (79 GBA)
- Catheter, Dilator (79 GCC)

Device Classification: Boston Scientific Corporation believes the proposed device is classified as a Class II device under:
- 21 CFR 876.5470; Ureteral Dilator
- 21 CFR 876.5520; Urethral Dilator
- 21 CFR 878.4200; Introduction/Drainage Catheter
- 21 CFR 876.5130; Urological Catheter

{1}

K965067
p292

# 510 (k) Summary Of Safety And Effectiveness Continued

## Description of Device:

The UDB Catheter is a combination over-the-wire, non-over-the-wire device. It consists of a two-lumen, catheter shaft with a molded bifurcation, a dilatation balloon and a Coudé tip. A 10 cc luer lock syringe is included in the tray.

## Intended Uses:

The UDB Catheter is intended to dilate constricted areas of the urethra, prostatic urethra and ureters.

## Substantial Equivalence:

The proposed devices are *Substantially Equivalent* to the predicate currently marketed devices indicated for use for dilatation of the urethra, prostatic urethra and ureters.

## Product Testing:

The proposed devices have been tested and compared to the predicate devices. The results indicate that the proposed devices are *Substantially Equivalent* to the predicate devices in terms of performance characteristics tested.