← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K963171

# CINCH QR SGW EXTENSION (K963171)

_Cordis Corp. · DQX · Nov 7, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K963171

## Device Facts

- **Applicant:** Cordis Corp.
- **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md)
- **Decision Date:** Nov 7, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for 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.

## 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

- CINCH® 3 Steerable Guidewire Extension ([K914863](/device/K914863.md))

## Reference Devices

- WIZDOM™ Steerable Guidewire ([K953760](/device/K953760.md))

## Submission Summary (Full Text)

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>
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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).

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K963171](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K963171)

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