Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1280](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1280) → NKS — Catheter, Steerable, Reprocessed

# NKS · Catheter, Steerable, Reprocessed

_Cardiovascular · 21 CFR 870.1280 · Class 2_

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

## Overview

- **Product Code:** NKS
- **Device Name:** Catheter, Steerable, Reprocessed
- **Regulation:** [21 CFR 870.1280](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1280)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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