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

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

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.

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)

Submission Summary (Full Text)

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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
[phone]
- **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.

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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.