Who is the manufacturer of CINCH QR SGW EXTENSION?

Cordis Corp. filed the 510(k) submission for CINCH QR SGW EXTENSION (K963171).

What is the FDA product code for CINCH QR SGW EXTENSION?

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

What is the regulatory pathway for CINCH QR SGW EXTENSION?

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

What are the predicate devices for CINCH QR SGW EXTENSION?

CINCH® 3 Steerable Guidewire Extension (K914863).

Who can help prepare an FDA 510(k) submission like CINCH QR SGW EXTENSION?

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.

CINCH QR SGW EXTENSION

K963171 · Cordis Corp. · DQX · Nov 7, 1996 · Cardiovascular

Device Facts

Record ID	K963171
Device Name	CINCH QR SGW EXTENSION
Applicant	Cordis Corp.
Product Code	DQX · Cardiovascular
Decision Date	Nov 7, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The Cordis CINCH® QR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter.

Device Story

Flexible stainless steel wire; 145 cm length; 0.014 inch shaft diameter; DURAGLIDE™ coated. Used as accessory to Cordis steerable guidewires; facilitates catheter exchange during interventional procedures. Operated by physicians in clinical settings. Device extends existing guidewire length to allow safe removal and replacement of catheters over the wire.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence based on material and design similarity to predicate.

Technological Characteristics

Stainless steel wire; DURAGLIDE™ coating; 145 cm length; 0.014 inch diameter. Mechanical device; no energy source or software.

Indications for Use

Indicated for use as an accessory to Cordis Steerable Guidewires to facilitate catheter exchange in patients requiring guidewire extension.

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

CINCH® 3 Steerable Guidewire Extension (K914863)

Reference Devices

WIZDOM™ Steerable Guidewire (K953760)

Related Devices

K101985 — ASAHI GUIDE WIRE EXTENSION 165CM · Asahi Intecc Co., Ltd. · Mar 7, 2011
K980119 — ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE · Guidant Corp. · Mar 20, 1998
K962572 — SCIMED CHOICE PT VISION PTCA GUIDE WIRE · Scimed Life Systems, Inc. · Dec 17, 1996
K030617 — PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE · Boston Scientific Scimed, Inc. · May 21, 2003
K961107 — B. BRAUN GUIDEWIRES · B.Braun Medical, Inc. · Oct 1, 1996

Submission Summary (Full Text)

{0} NOV - 7 1996 K963171 # PREMARKET NOTIFICATION 510(k) ## Cordis Corporation ### Cinch® QR Steerable Guidewire Extension ## SUMMARY OF SAFETY AND EFFECTIVENESS ### I. General Provisions - Common or Usual Name: Catheter Guide Wire (Accessory) - Proprietary Name: Cordis CINCH® QR Steerable Guidewire Extension ### II. Name of Predicate Devices - CINCH® 3 Steerable Guidewire Extension ### III. Classification - Catheter Guide Wire Accessory, Class II - 21 CFR 870.1330 ### 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 Cordis CINCH® QR Steerable Guidewire Extension is designed to extend Cordis Steerable Guidewires so that a catheter can be exchanged for another catheter. The CINCH® QR Steerable Guidewire Extension is a flexible stainless steel wire coated with DURAGLIDE™. The extension is 145 cm long and has a shaft diameter of 0.014 inches. ### VI. Biocompatibility Biocompatibility testing was not repeated since the CINCH® QR and the currently marketed CINCH® 3 (K914863) Steerable Guidewire Extensions are made of the same materials. The DURAGLIDE™ coating and method of application have also been cleared for use with the WIZDOM™ Steerable Guidewire (K953760).