← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K955637

# ESSENCE GUIDEWIRE (K955637)

_Cordis Neurovascular, Inc. · DQX · Mar 11, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K955637

## Device Facts

- **Applicant:** Cordis Neurovascular, Inc.
- **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md)
- **Decision Date:** Mar 11, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The ESSENCE™ Guidewires are intended for the introduction and positioning of catheters and interventional devices within the peripheral, coronary and neurovascular systems. The guidewires have a soft, flexible tip and may be used with intravascular devices what are indicated for use with such guidewires.

## Device Story

Steerable guidewire; soft, flexible tip; facilitates introduction/positioning of catheters and interventional devices; used in peripheral, coronary, and neurovascular systems; operated by clinicians during interventional procedures; provides mechanical support/guidance for intravascular devices.

## Clinical Evidence

No clinical data; biocompatibility testing performed.

## Technological Characteristics

Stainless steel steerable guidewire; soft, flexible tip; mechanical device; no software or energy source.

## Regulatory Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Predicate Devices

- Cordis Endovascular Systems, Inc. Instinct® Steerable Guidewire ([K930982](/device/K930982.md))
- Cordis Corporation Reflex Steerable Guidewire ([K905432](/device/K905432.md))
- Target Therapeutics Dasher Guidewire ([K914030](/device/K914030.md))

## 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.
>
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{0}

PREMARKET NOTIFICATION 510(k)
Cordis Endovascular Systems, Inc.
ESSENCE™ Stainless Steel Guidewire
0-000015

# SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 11 1982

## I. General Provisions:

K94637

Common or Usual Name: Steerable Guidewire

Proprietary Name: ESSENCE™ Guidewire

## II. Name of Predicate Devices

Cordis Endovascular Systems, Inc. Instinct® Steerable Guidewire (K930982)

Cordis Corporation Reflex Steerable Guidewire (K905432)

Target Therapeutics Dasher Guidewire (K914030)

## 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

The ESSENCE™ Guidewires are intended for the introduction and positioning of catheters and interventional devices within the peripheral, coronary and neurovascular systems. The guidewires have a soft, flexible tip and may be used with intravascular devices what are indicated for use with such guidewires.

## VI. Biocompatibility

All appropriate biocompatibility tests were successfully performed on the Cordis Endovascular Systems, Inc. ESSENCE™ Guidewire.

## VII. Summary of Substantial Equivalence

The ESSENCE™ Guidewires are similar in its basic design, construction, indication for use and performance characteristics to other commercially available steerable guidewires.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K955637](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K955637)

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