NKS · Catheter, Steerable, Reprocessed

Cardiovascular · 21 CFR 870.1280 · Class 2

Overview

Product CodeNKS
Device NameCatheter, Steerable, Reprocessed
Regulation21 CFR 870.1280
Device ClassClass 2
Review PanelCardiovascular
3rd-Party ReviewableYes

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.

Innolitics

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