← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K962932

# CORDIS STABILIZER PLUS XS (K962932)

_Cordis Corp. · DQX · Oct 25, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K962932

## Device Facts

- **Applicant:** Cordis Corp.
- **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md)
- **Decision Date:** Oct 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The Cordis STABILIZER Plus XS Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

## Device Story

Steerable guidewire; extra support version of WIZDOM guidewire. Input: manual manipulation by physician during angiographic procedures. Function: provides structural support for introduction of interventional devices (e.g., stents) into coronary/peripheral vasculature. Output: physical guidance/pathway for catheters. Used in clinical/interventional settings; operated by physicians. Benefit: facilitates delivery of bulky interventional devices.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Steerable guidewire; utilizes larger diameter corewires and modified tapers compared to conventional WIZDOM guidewire for increased support. Materials identical to predicate WIZDOM guidewire. Class II device (21 CFR 870.1330).

## 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 WIZDOM Steerable Guidewire ([K953760](/device/K953760.md))
- Meditech/Boston Scientific Platinum Plus™ Guidewire ([K935997](/device/K935997.md))
- Scimed/Boston Scientific Platinum Plus™ Coronary Guidewire

## 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.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

OCT 25 1996
K962932

# PREMARKET NOTIFICATION

Cordis Corporation
STABILIZER™ Plus XS Steerable Guidewire

## SUMMARY OF SAFETY AND EFFECTIVENESS

### I. General Provisions

Common or Usual Name: Catheter Guide Wire

Proprietary Name: Cordis STABILIZER Plus XS Steerable Guidewire

### II. Name of Predicate Devices

Cordis WIZDOM Steerable Guidewire (K953760)
Meditech/Boston Scientific Platinum Plus™ Guidewire (K935997)
Scimed/Boston Scientific Platinum Plus™ Coronary Guidewire

### III. Classification

Catheter Guide Wire, Class II - 21 CFR 870.1330
74DQX - Cardiovascular

### 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 STABILIZER Plus XS Steerable Guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Cordis STABILIZER Plus XS Steerable Guidewire is an extra support version of the Cordis WIZDOM Steerable Guidewire. The extra support versions of the WIZDOM Steerable Guidewire utilize slightly larger diameter corewires and different tapers compared to the conventional WIZDOM guidewire in order to provide the extra support required for bulkier device (such as a stent) introduction.

### VI. Biocompatibility

The materials incorporated into the STABILIZER Plus XS are exactly the same as the materials used for the currently marketed WIZDOM Steerable Guidewire.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K962932](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K962932)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com