← Product Code [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX) · K001033

# AGILITY STEERABLE GUIDEWIRE (K001033)

_Cordis Neurovascular, Inc. · DQX · Apr 14, 2000 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K001033

## Device Facts

- **Applicant:** Cordis Neurovascular, Inc.
- **Product Code:** [DQX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX.md)
- **Decision Date:** Apr 14, 2000
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.1330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## 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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K001033](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQX/K001033)

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