Who is the manufacturer of ESSENCE GUIDEWIRE?

Cordis Neurovascular, Inc. filed the 510(k) submission for ESSENCE GUIDEWIRE (K955637).

What is the FDA product code for ESSENCE GUIDEWIRE?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ESSENCE GUIDEWIRE?

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

Who can help prepare an FDA 510(k) submission like ESSENCE GUIDEWIRE?

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.

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)

Related Devices

K963214 — CORDIS ST STEERABLE GUIDEWIRE · Cordis Corp. · Nov 13, 1996
K100470 — GTX 12 GIDEWIRE · Medtronic, Inc. · Apr 21, 2010
K202522 — Synchro SELECT Guidewire · Stryker Neurovascular · Sep 25, 2020
K992237 — MEDTRONIC GT2 FUSION GUIDE WIRES · Medtronic Vascular · Sep 9, 1999
K140695 — COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE · Medtronic, Inc. · Jun 12, 2014

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.