← Product Code [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA) · K955534 # SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) (K955534) _International Innovations, Inc. · KRA · Aug 1, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K955534 ## Device Facts - **Applicant:** International Innovations, Inc. - **Product Code:** [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA.md) - **Decision Date:** Aug 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The Segue™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps. ## Device Story Single lumen, over-the-wire infusion catheter; delivers fluids locally into peripheral vasculature. Used in clinical settings by physicians. Device provides targeted delivery of therapeutic agents; benefits patient via localized treatment. Manual operation; no power injection. Physical testing confirms structural integrity, flow rates, and trackability. ## Clinical Evidence Bench testing: dimensional inspection, deployment/recoil, marker band attachment, flow rate, pressurization, bond strength, flexural fatigue, radial force, trackability. Biocompatibility testing passed. Animal studies: assessed vessel placement and thrombus accumulation; no adverse results reported. ## Technological Characteristics Single lumen, over-the-wire catheter. Materials biocompatibility tested. Mechanical design features marker bands for visualization. Manual infusion delivery; not compatible with power injection pumps. ## Regulatory Identification A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping. ## Predicate Devices - FasTRACKER® Infusion Catheter (Target Therapeutics) ## 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} K955534 AUG 1 1996 510(k) Summary *Segue™* Infusion Catheter Trade Name: *Segue™* Infusion Catheter Classification Name: Catheter, Percutaneous Classification: Class II Submitted By: Interventional Innovations Corporation 2670 Patton Road St. Paul, MN 55113 (612) 636-6634 Contact: Karen Peterson Director of Clinical and Regulatory Affairs Predicate Device: FasTRACKER® Infusion Catheter Target Therapeutics ## Device Description The *Segue™* Infusion Catheter is a single lumen, over-the-wire device designed to locally deliver fluids into the peripheral (non-coronary, non-cerebral) vasculature. ## Intended Use The *Segue™* Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps. ## Testing Physical testing of the product under simulated conditions included: dimensional inspection, deployment and recoil verification, marker band attachment, infusion flow rate, internal pressurization, bond strength, flexural fatigue strength, radial force and trackability. All testing results were within product engineering and marketing specifications. Biocompatibility testing was performed on the sterile materials used in the construction of this infusion catheter. All materials passed the biocompatibility testing and are suitable for this application. {1} Animal studies were conducted to assess placement of the device in a vessel as well as thrombus accumulation on the device. There were no adverse results reported. ## Summary of Substantial Equivalence The Segue™ Infusion Catheter is constructed of the same or substantially equivalent materials as found in the predicate device. The sizes and configurations available are comparable as is the packaging methods and materials. The clinical indications for use are substantially equivalent to those of the predicate device. Because of the similarities in materials, construction, indications for use, packaging and testing results, this product does not raise any new safety or effectiveness issues. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K955534](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K955534) **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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