← Product Code [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA) · K955525 # FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70 (K955525) _Interventional Innovations Corp. · KRA · Aug 8, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K955525 ## Device Facts - **Applicant:** Interventional Innovations Corp. - **Product Code:** [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA.md) - **Decision Date:** Aug 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1210 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Indications for Use The Flower™ 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 Multi-lumen, over-the-wire infusion catheter; delivers fluids locally into peripheral vasculature. Used by clinicians in interventional settings. Device tracks over guidewire to target site; fluid infused via lumen. Benefits include targeted local delivery of therapeutic agents. No power injection or thrombolytic use permitted. ## Clinical Evidence Bench testing: dimensional inspection, deployment/recoil, marker band attachment, flow rate, pressurization, bond strength, flexural fatigue, radial force, trackability, guide catheter compatibility. Biocompatibility testing: all materials passed. Animal testing: assessed vessel placement and thrombus accumulation; results satisfactory. ## Technological Characteristics Multi-lumen, over-the-wire catheter. Materials biocompatibility verified. Sterilization method equivalent to predicate. Design features include marker bands for visualization. ## 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} AUG - 8 1996 K955525 # 510(k) Summary ## Flower™ Infusion Catheter ### General Information - **Trade Name:** Flower™ Infusion Catheter - **Classification Name:** Catheter, Percutaneous - **Classification:** Class II - **Submitted By:** Interventional Innovations Corp. 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 Flower™ Infusion Catheter is a multi-lumen, over-the-wire device designed to locally deliver fluids into the peripheral vasculature. ### Intended Use The Flower™ 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, trackability, and guide catheter compatibility. All testing results were within product engineering and marketing specifications. Biocompatibility testing was performed on the sterile materials used in the construction of these infusion catheters. All materials passed the biocompatibility testing and are suitable for this application. {1} Animal testing was conducted to assess placement of the device in a vessel as well as thrombus accumulation on the device. All results were satisfactory. ## Summary of Substantial Equivalence The Flower™ Infusion Catheter is constructed of the same or substantially equivalent materials to the predicate device. The sizes and configurations available along with the packaging and sterilization methods are also equivalent. 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/K955525](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K955525) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com