K260499

Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

510(k) number
K260499
Device name
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 MN · US
Product code
DQY — Catheter, Percutaneous
Decision date
2026-03-13
Date received
2026-02-13
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Cardiovascular
510(k) Summary (official FDA PDF): K260499.pdf
Official FDA record: K260499
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.