Cleared Traditional

K250552 - Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250552 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
150d
Days
Class 2
Risk

K250552 is an FDA 510(k) clearance for the Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Abbott Medical (Santa Clara, US). The FDA issued a Cleared decision on July 25, 2025 after a review of 150 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

Submission Details

510(k) Number K250552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2025
Decision Date July 25, 2025
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K250552.
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