← Product Code [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA) · K965181

# CES INFUSION CATHETER (K965181)

_Cordis Neurovascular, Inc. · KRA · Mar 21, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K965181

## Device Facts

- **Applicant:** Cordis Neurovascular, Inc.
- **Product Code:** [KRA](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA.md)
- **Decision Date:** Mar 21, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1210
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **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.

## 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

- TRANSIT® Infusion Catheter (Cordis Endovascular Systems, Inc.)
- RapidTRANSIT® Infusion Catheter (Cordis Endovascular Systems, Inc.)
- Tracker Infusion Catheters (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}

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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K965181](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/KRA/K965181)

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