Cleared Special

Amulet? Steerable Delivery Sheath

K250426 · Abbott Medical · Cardiovascular
Apr 2025
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K250426 is an FDA 510(k) clearance for the Amulet? Steerable Delivery Sheath, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Abbott Medical (St.Paul, US). The FDA issued a Cleared decision on April 25, 2025, 70 days after receiving the submission on February 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K250426 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2025
Decision Date April 25, 2025
Days to Decision 70 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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