← Product Code [DYG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG) · K961999 # SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS (K961999) _Boston Scientific Scimed, Inc. · DYG · Nov 19, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K961999 ## Device Facts - **Applicant:** Boston Scientific Scimed, Inc. - **Product Code:** [DYG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG.md) - **Decision Date:** Nov 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1240 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Schneider (USA) Inc Pfizer Hospital Products Group 5905 Nathan Lane Minneapolis, MN 55442 Tel 612 550 5500 Fax 612 550 5771 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: (612)550-5500 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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K961999](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K961999) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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