Cleared Special

K251211 - ViewFlex™ Xtra ICE Catheter (FDA 510(k) Clearance)

Also includes:
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™

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251211 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
35d
Days
Class 2
Risk

K251211 is an FDA 510(k) clearance for the ViewFlex™ Xtra ICE Catheter. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Abbott Medical (Plymouth, US). The FDA issued a Cleared decision on May 23, 2025 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Medical devices

Submission Details

510(k) Number K251211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OBJ Catheter, Ultrasound, Intravascular

All 77
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K251211.
Novasight Hybrid System
K252945 · Conavi Medical, Inc. · Apr 2026
OptiCross Coronary Imaging Catheter (H749518110)
K260816 · Boston Scientific · Apr 2026
Visions® PV .014P RX Digital IVUS Catheter
K253399 · Volcano Corporation (Dba Philips Image Guided Therapy Device · Oct 2025
XC11 ICE System, USA
K250955 · Yorlabs, Inc. · Oct 2025
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
K250913 · Jiangsu Tingsn Technology Co., Ltd. · Jul 2025
ViewFlex™ X ICE Catheter, Sensor Enabled™
K251231 · Abbott Medical · May 2025