Cleared Special

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 · Cardiovascular

Mar 2026

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K260499 is an FDA 510(k) clearance for the Amplatzer? Trevisio? Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Abbott Medical (St. Paul, US). The FDA issued a Cleared decision on March 13, 2026, 28 days after receiving the submission on February 13, 2026. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K260499 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2026
Decision Date	March 13, 2026
Days to Decision	28 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF