LAGUNA SOFTIP DIAGNOSTIC CATHETERS
Device Facts
| Record ID | K961499 |
|---|---|
| Device Name | LAGUNA SOFTIP DIAGNOSTIC CATHETERS |
| Applicant | Boston Scientific Scimed, Inc. |
| Product Code | DQO · Cardiovascular |
| Decision Date | Oct 17, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
Intended Use
The LAGUNA™ Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.
Device Story
Diagnostic catheter; 5, 6, and 7 French sizes; multiple distal stem configurations/lengths. Used for delivery of radiopaque media to vascular sites. Physician-operated in clinical setting. Provides vascular access for contrast media injection. Benefits patient by enabling diagnostic imaging of vascular system.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Catheter available in 5, 6, 7 FR sizes. Features include variable distal stem configurations and handling characteristics. Testing performed: bond strength, flexural rigidity, bodystock force delay, tip shape recovery, flow rate, pressure injection/leak, output torque, input torque to failure, distal pressure.
Indications for Use
Indicated for patients requiring delivery of radiopaque media to selected sites in the vascular system.
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
- Softip® High Flow diagnostic catheter (5 FR, 7 FR)
- INFINITI™ diagnostic catheter (5 FR)
- SUPER TORQUEPLUS™ diagnostic catheter (7 FR)
- GUIDEZILLA™ Softip® guiding catheters
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- K970854 — 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER · Cordis Corp. · Sep 30, 1997
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