ESSENCE GUIDEWIRE

K955637 · Cordis Neurovascular, Inc. · DQX · Mar 11, 1996 · Cardiovascular

Device Facts

• Record ID: K955637
• Device Name: ESSENCE GUIDEWIRE
• Applicant: Cordis Neurovascular, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for introduction and positioning of catheters and interventional devices within peripheral, coronary, and neurovascular systems.

Regulatory Classification

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)
• Cordis Corporation Reflex Steerable Guidewire (K905432)
• Target Therapeutics Dasher Guidewire (K914030)

Submission Summary (Full Text)

{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.