SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS

K961999 · Boston Scientific Scimed, Inc. · DYG · Nov 19, 1996 · Cardiovascular

Device Facts

• Record ID: K961999
• Device Name: SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
• Applicant: Boston Scientific Scimed, Inc.
• Product Code: DYG · Cardiovascular
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1240
• Device Class: Class 2

Intended Use

The SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.

Device Story

Guiding catheter; used for intravascular introduction of interventional devices. Available in 6-10 FR sizes; multiple distal stem configurations/lengths; varying handling characteristics. Operated by physicians in clinical settings. Provides conduit for interventional tools; facilitates device delivery to target vasculature.

Clinical Evidence

Bench testing only. Performance metrics: bond strength, flexural rigidity, bodystock force delay, tip shape recovery, introducer resistance, inner liner lubricity, flow rate, pressure injection/leak test, and torque to failure.

Technological Characteristics

Catheter sizes 6-10 FR; multiple distal configurations. Materials biocompatibility per ISO 10993-1. Performance characteristics: flexural rigidity, torque, tip recovery, lubricity, flow rate, pressure resistance.

Indications for Use

Indicated for patients requiring intravascular introduction of interventional devices.

Regulatory Classification

Identification

A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

Predicate Devices

• Petite brite tip® guiding catheter (6 FR)
• Vista brite tip™ guiding catheter (10 FR)
• TRIGUIDE® guiding catheter (10 FR)
• DVI guiding catheter (10 FR)
• SOLID-7 guiding catheter

Submission Summary (Full Text)

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Schneider (USA) Inc
Pfizer Hospital Products Group
5905 Nathan Lane
Minneapolis, MN 55442
Tel [phone] Fax [phone]
NOV 19 1996
K961999
Schneider
510(k) Summary for SCHNEIDER GUIDER Softip® guiding catheter

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is 15961999

Date Prepared: May 21, 1996

Sponsor: Schneider (USA) Inc
5905 Nathan Lane
Plymouth, MN 55442
Phone: [phone]

Contact: Maria Brittle
Sr. Regulatory Affairs Specialist

Trade/Proprietary Name: SCHNEIDER GUIDER Softip® guiding catheters
Classification: Class II
Equivalent Devices
Petite brite tip® guiding catheter (6 FR)
Vista brite tip™ guiding catheter (10 FR)
TRIGUIDE® guiding catheter (10 FR)
DVI guiding catheter (10 FR)
SOLID-7 guiding catheter (packaging only)

Device Description
The SCHNEIDER GUIDER guiding catheter is manufactured in five French sizes (6 through 10 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 SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.

Technological Characteristics
The following invitro performance tests were conducted with the SCHNEIDER GUIDER Softip® guiding catheters and approved predicate devices to show equivalence: bond strength tests, flexural rigidity, bodystock force delay, tip shape recovery, introducer resistance, inner liner ubricity, flow rate, pressure injection/leak test, output input torque to failure. Materials equivalence was demonstrated through biocompatibility testing following ISO 10993-1 recommendations.

The results of these tests indicated that the SCHNEIDER GUIDER Softip® guiding catheters are equivalent to the previously approved predicate devices and are, therefore, safe for the intended use.