IMAGER TORQUE CATHETER

K965229 · Boston Scientific Corp · KOD · Mar 4, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K965229
• Device Name: IMAGER TORQUE CATHETER
• Applicant: Boston Scientific Corp
• Product Code: KOD · Gastroenterology, Urology
• Decision Date: Mar 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The Imager Torque Catheter is indicated for use for catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials.

Device Story

Single-lumen introduction catheter; flexible body; single distal tip hole; proximal luer lock hub. Compatible with .038” guidewire. Used by clinicians for delivery of radiopaque contrast materials into urinary or gastrointestinal tracts. Facilitates diagnostic imaging procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-lumen catheter; flexible construction; luer lock hub; .038” guidewire compatibility.

Indications for Use

Indicated for patients requiring catheterization of the urinary or gastrointestinal tract for the administration of radiopaque contrast media.

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).

Predicate Devices

• Introduction / Drainage Catheter (CFR 21 part 878.4200)

Submission Summary (Full Text)

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K965229

# 510(k) Summary Of Safety And Effectiveness

MAR - 4 1997

FOI RELEASABLE

| Sponsor: | Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537 |
| --- | --- |
| Contact Person: | Carol J. Holloway
Regulatory Affairs Specialist |
| Submission Date: | December 27, 1996 |
| Description of Device: | The Imager Torque Catheter is a single - lumen introduction catheter with a range of tip configurations. The device is flexible catheter with one hole at the tip. A luer lock hub is attached to the proximal end. The catheter is designed to be used with a .038” guidewire if required. |
| Intended Uses: | The Imager Torque Catheter is indicated for use for catheterization in the urinary tract or gastrointestinal tract for the introduction of radiopaque contrast materials. |
| Substantial Equivalence: | The proposed devices are Substantially Equivalent to the predicate currently marketed devices indicated for use for catheterization in the cardiovascular system for the introduction of radiopaque contrast materials and CFR 21 part 878.4200, Introduction / Drainage Catheter. |