Cleared Traditional

K250031 - Amplatzer Guidewire

K250031 is an FDA 510(k) clearance for Amplatzer Guidewire, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K250031 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
269d
Days
Class 2
Risk

K250031 is an FDA 510(k) clearance for the Amplatzer Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Medical (St. Paul, US). The FDA issued a Cleared decision on October 3, 2025 after a review of 269 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Medical devices

FDA 510(k) Submission Details - K250031

510(k) Number K250031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2025
Decision Date October 03, 2025
Days to Decision 269 days
Submission Type Traditional
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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K250031.
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026
Lunderquist Extra Stiff Wire Guide
K251596 · William Cook Europe Aps · Nov 2025
SureAx-Guide™
K250203 · Sureax Medical, LLC · Oct 2025
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5)
K251181 · Merit Medical Ireland, Ltd. · Aug 2025
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K250552 · Abbott Medical · Jul 2025
Medtronic Stedi Extra Support Guidewire
K250075 · Medtronic, Inc. · Jun 2025