EVT ANGIOSCALE ANGIOGRAPHIC CATHETER

K970469 · Guidant Cardiac and Vascular Surgery · DQO · May 8, 1997 · Cardiovascular

Device Facts

• Record ID: K970469
• Device Name: EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
• Applicant: Guidant Cardiac and Vascular Surgery
• Product Code: DQO · Cardiovascular
• Decision Date: May 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

Device Story

Diagnostic intravascular catheter; PEBAX pigtail design; 6-7 French; 0.038” guidewire compatible. Features 11-20 radiopaque platinum marker bands along tubing. Used by physicians in clinical settings for angiographic visualization. Marker bands function as scaled ruler during imaging to provide linear measurements of vasculature. Contrast media injected via proximal polycarbonate luer adapter; dispersed through distal ports. Disposable; single-procedure use; provided sterile.

Clinical Evidence

Bench testing only.

Technological Characteristics

PEBAX catheter body; radiopaque platinum marker bands; polycarbonate luer adapter. 6-7 French diameter; 0.038” guidewire compatibility. Sterile, single-use, disposable. No software or electronic components.

Indications for Use

Indicated for angiographic visualization and linear measurement of the vasculature in patients requiring contrast media delivery to selected vascular sites.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Cordis Standard and High Flow Femoral-Ventricular Pigtail Catheters (K862006)
• Cordis 5.2 French Super Torque Plus Cardiology Catheter (K914007)
• Cordis Quanticor Marker Catheter
• Cordis Ducor Angiographic Catheter

Submission Summary (Full Text)

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MAY - 8 1997
K970469

## II. SUMMARY AND CERTIFICATION

### Summary of Safety and Effectiveness

#### Manufacturer:
EndoVascular Technologies, Inc.
1460 O'Brien Drive
Menlo Park, CA 94025-1436
Contact: Luanne Termeer

#### Device Name:
The EVT® AngioScale™ angiographic catheter is a diagnostic intravascular catheter, 21 CFR 870.1200, Class II.

#### Substantial Equivalence:
The EVT® AngioScale™ angiographic catheter is substantially equivalent to the Cordis Standard and High Flow Femoral-Ventricular Pigtail Catheters (K862006, Class II), the Cordis 5.2 French Super Torque Plus Cardiology Catheter (K914007, Class II), the Cordis Quanticor Marker Catheter (Class II), and the Cordis Ducor Angiographic Catheter (Class II).

#### Device Description:
The EVT AngioScale angiography catheter is a PEBAX pigtail catheter with 11 to 20 radiopaque platinum marker bands on the catheter tubing. This 6 - 7 French catheter rides over a .038” guide wire. A standard polycarbonate luer adapter at the proximal end allows for injection of contrast media. Distal ports disperse the contrast media for angiographic visualization.

The EVT AngioScale angiography catheter has multiple radiopaque platinum marker bands so that the entire length of the marked catheter image can be used as a scaled ruler.

The EVT AngioScale angiography catheter is provided sterile to the end user. It is disposable, with a useable life of one procedure.

#### Intended Use:
The EVT AngioScale angiography catheters provides angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

CONFIDENTIAL
EndoVascular Technologies, Inc.
Page 2
February 6, 1997
EVT® AngioScale™ 510(k)