Cleared Special

Amulet? Steerable Delivery Sheath

K232690 · Abbott Medical · Cardiovascular
Sep 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K232690 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 September 29, 2023, 28 days after receiving the submission on September 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K232690 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2023
Decision Date September 29, 2023
Days to Decision 28 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

Similar Devices — DQY Catheter, Percutaneous

All 885
Amplatzer? Trevisio? Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
K260499 · Abbott Medical · Mar 2026
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo? Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025
Telescope Guide Extension Catheter
K252390 · Medtronic, Ireland · Oct 2025
CPS Locator 3D Delivery Catheter
K250147 · Centerpoint Systems · Aug 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277 · Reflow Medical, Inc. · Aug 2025