Cleared Special

ViewFlex? Xtra ICE Catheter; ViewFlex? Eco Reprocessed ICE Catheter; Advisor? HD Grid Mapping Catheter, Sensor Enabled?; Advisor? HD Grid X Mapping Catheter, Sensor Enabled?; Agilis? NxT Steerable Introducer; Agilis? NxT Steerable Introducer Dual-Reach?

K251211 · Abbott Medical · Cardiovascular

May 2025

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K251211 is an FDA 510(k) clearance for the ViewFlex? Xtra ICE Catheter; ViewFlex? Eco Reprocessed ICE Catheter; Advisor? HD Grid Mapping Catheter, Sensor Enabled?; Advisor? HD Grid X Mapping Catheter, Sensor Enabled?; Agilis? NxT Steerable Introducer; Agilis? NxT Steerable Introducer Dual-Reach?, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Abbott Medical (Plymouth, Mn, US). The FDA issued a Cleared decision on May 23, 2025, 35 days after receiving the submission on April 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K251211 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2025
Decision Date	May 23, 2025
Days to Decision	35 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	OBJ — Catheter, Ultrasound, Intravascular
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1200
Definition	For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.