CES INFUSION CATHETER

K965181 · Cordis Neurovascular, Inc. · KRA · Mar 21, 1997 · Cardiovascular

Device Facts

• Record ID: K965181
• Device Name: CES INFUSION CATHETER
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

CES Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic and embolic agents into the peripheral, coronary and neurovasculatures.

Device Story

CES Infusion Catheters; diagnostic/embolic agent delivery device. Used in peripheral, coronary, and neurovasculatures. Operated by clinicians. Design and construction similar to predicate infusion catheters. Biocompatibility testing performed.

Clinical Evidence

Bench testing only; biocompatibility testing successfully performed.

Technological Characteristics

Intravascular catheter; design and construction consistent with commercially available infusion catheters. Biocompatible materials.

Indications for Use

Indicated for infusion of diagnostic and embolic agents into peripheral, coronary, and neurovasculatures.

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

• TRANSIT® Infusion Catheter (Cordis Endovascular Systems, Inc.)
• RapidTRANSIT® Infusion Catheter (Cordis Endovascular Systems, Inc.)
• Tracker Infusion Catheters (Target Therapeutics)

Submission Summary (Full Text)

{0}

MAR 21 1997
K965181
0-000015

# PREMARKET NOTIFICATION 510(k)
Cordis Endovascular Systems, Inc.
CES Infusion Catheters
Modification

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. General Provisions:

Common or Usual Name: Diagnostic, Intravascular Catheter

Proprietary Name: CES Infusion Catheters

## II. Name of Predicate Devices

1. Trade Name: TRANSIT® Infusion Catheter
Manufacturer: Cordis Endovascular Systems, Inc.

2. Trade Name: RapidTRANSIT® Infusion Catheter
Manufacturer: Cordis Endovascular Systems, Inc

3. Trade Name: Tracker Infusion Catheters
Manufacturer: Target Therapeutics

## III. Classification:

Class II

## IV. Performance Standards:

Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.

## V. Intended Use and Device Description

CES Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic and embolic agents into the peripheral, coronary and neurovasculatures.

## VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on the CES Infusion Catheters.

## VII. Summary of Substantial Equivalence

The CES Infusion Catheters are similar in its basic design, construction, indication for use and performance characteristics to other commercially available infusion catheters.