Cleared Traditional

EP?XT? Unidirectional Steerable Diagnostic Catheter; Dynamic Tip? Unidirectional Steerable Diagnostic Catheter; Dynamic XT? Unidirectional Steerable Diagnostic Catheter

K240366 · Boston Scientific Corporation · Cardiovascular

Nov 2024

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K240366 is an FDA 510(k) clearance for the EP?XT? Unidirectional Steerable Diagnostic Catheter; Dynamic Tip? Unidirectional Steerable Diagnostic Catheter; Dynamic XT? Unidirectional Steerable Diagnostic Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Boston Scientific Corporation (Alternate Contact, US). The FDA issued a Cleared decision on November 1, 2024, 269 days after receiving the submission on February 6, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K240366 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2024
Decision Date	November 01, 2024
Days to Decision	269 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