Who is the manufacturer of SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

International Innovations, Inc. filed the 510(k) submission for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) (K955534).

What is the FDA product code for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

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

What is the regulatory pathway for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

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

Who can help prepare an FDA 510(k) submission like SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

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.

SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)

Q: What are the predicate devices for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

FasTRACKER® Infusion Catheter (Target Therapeutics).

K955534 · International Innovations, Inc. · KRA · Aug 1, 1996 · Cardiovascular

Device Facts

Record ID	K955534
Device Name	SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)
Applicant	International Innovations, Inc.
Product Code	KRA · Cardiovascular
Decision Date	Aug 1, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1210
Device Class	Class 2
Attributes	Therapeutic

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.

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.

Indications for Use

Indicated for delivery of therapeutic agents into peripheral vasculature; excludes coronary and cerebral vasculature; excludes use with thrombolytics or 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

K955525 — FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70 · Interventional Innovations Corp. · Aug 8, 1996
K964154 — SEGUE INFUSION CATHETER · Interventional Innovations Corp. · Jan 14, 1997
K093431 — CLEARWAY OTW MODEL 85912 · Atrium Medical Corp. · Apr 20, 2010
K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER · Medi-Tech, Inc. · May 15, 1996
K963988 — INTRAVASCULAR INFUSION DEVICE · Boston Scientific Corp · Dec 12, 1996

Submission Summary (Full Text)

{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.