← Product Code [DQO](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO) · K961499

# LAGUNA SOFTIP DIAGNOSTIC CATHETERS (K961499)

_Boston Scientific Scimed, Inc. · DQO · Oct 17, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K961499

## Device Facts

- **Applicant:** Boston Scientific Scimed, Inc.
- **Product Code:** [DQO](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO.md)
- **Decision Date:** Oct 17, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1200
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for 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.

## Regulatory 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

## Submission Summary (Full Text)

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{0}

Pfizer Hospital Products Group
5905 Nathan Lane
Minneapolis, MN 55442
Tel 612 550 5500 Fax 612 550 5771

Pfizer
OCT 17 1996
SCHNEIDER

510(k) Summary for
LAGUNA™ Softip® diagnostic catheter

Date Prepared: April 17, 1996
K 961499

Sponsor: Schneider (USA) Inc
5905 Nathan Lane
Plymouth, MN 55442
Phone: (612)550-5500

Contact: Maria Brittle
Sr. Regulatory Affairs Specialist

Trade/Proprietary Name: LAGUNA™ Softip® diagnostic catheter

Classification: Class II

Equivalent 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 (packaging & sterilization)

Device Description
The LAGUNA™ diagnostic catheter is manufactured in three French sizes (5 FR, 6 FR and 7 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.

Intended Use
The LAGUNA™ Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.

Technological Characteristics
The following tests were performed on the LAGUNA™ Softip® diagnostic catheters and approved predicate device to show equivalence: bond strength tests, flexural rigidity, bodystock force delay, tip shape recovery, flow rate, pressure injection/leak test, output torque, input torque to failure and distal pressure testing.

The results of these tests indicate that the LAGUNA™ Softip® diagnostic catheters are equivalent to the previously approved predicate device and is therefore safe for its intended use.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K961499](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQO/K961499)

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