Amplatzer Trevisio Intravascular Delivery System +1 more— 510(k) K260499

Name: FDA 510(k) clearance K260499
Creator: U.S. Food and Drug Administration
Published: 2026-03-13

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K260499 for Amplatzer Trevisio Intravascular Delivery System +1 more, Substantially Equivalent on 2026-03-13. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Device name as filed: Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
Applicant: ABBOTT MEDICAL
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2026-02-13
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.