Who is the manufacturer of FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70?

Interventional Innovations Corp. filed the 510(k) submission for FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70 (K955525).

What is the FDA product code for FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70?

KRA. It is classified under 21 CFR 870.1210 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70

Q: What are the predicate devices for FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70?

FasTRACKER® Infusion Catheter (Target Therapeutics).

K955525 · Interventional Innovations Corp. · KRA · Aug 8, 1996 · Cardiovascular

Device Facts

Record ID	K955525
Device Name	FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
Applicant	Interventional Innovations Corp.
Product Code	KRA · Cardiovascular
Decision Date	Aug 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1210
Device Class	Class 2
Attributes	Therapeutic

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.

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.

Indications for Use

Indicated for delivery of therapeutic agents into peripheral vasculature. Contraindicated for coronary or cerebral vasculature, use with thrombolytics, or use with power injection pumps.

Regulatory Classification

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)

Related Devices

K964154 — SEGUE INFUSION CATHETER · Interventional Innovations Corp. · Jan 14, 1997
K955534 — SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) · International Innovations, Inc. · Aug 1, 1996
K082199 — SPIRALFUSE PERIPHERAL INFUSION SYSTEM · Bacchus Vascular, Inc. · Oct 17, 2008
K073400 — VARICATH PERIPHERAL INFUSION CATHETER · Veinrx, Inc. · Dec 20, 2007
K202347 — UNIFUSE Infusion System with Cooper Wire · AngioDynamics, Inc. · Sep 15, 2020

Submission Summary (Full Text)

{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.