Cleared Traditional

Armada? 14 NC PTA Catheter

K252512 · Abbott Medical · Cardiovascular
Feb 2026
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K252512 is an FDA 510(k) clearance for the Armada? 14 NC PTA Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Abbott Medical (S,Mta Clara, US). The FDA issued a Cleared decision on February 13, 2026, 186 days after receiving the submission on August 11, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K252512 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2025
Decision Date February 13, 2026
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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