Cleared Traditional

Polaris X? Catheter Cable, Blazer? Dx-20 Catheter Cable

K230503 · Boston Scientific · Cardiovascular

Apr 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K230503 is an FDA 510(k) clearance for the Polaris X? Catheter Cable, Blazer? Dx-20 Catheter Cable, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Boston Scientific (St. Paul, US). The FDA issued a Cleared decision on April 25, 2023, 60 days after receiving the submission on February 24, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K230503 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2023
Decision Date	April 25, 2023
Days to Decision	60 days
Submission Type	Traditional
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