Cleared Special

Polaris X? Unidirectional Steerable Diagnostic Catheter

K233207 · Boston Scientific Corporation · Cardiovascular

Oct 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K233207 is an FDA 510(k) clearance for the Polaris X? Unidirectional Steerable Diagnostic Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Boston Scientific Corporation (St. Paul, US). The FDA issued a Cleared decision on October 27, 2023, 29 days after receiving the submission on September 28, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K233207 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	October 27, 2023
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1220