Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-A
Summary
ABBOTT MEDICAL received 510(k) clearance for Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80, a DQY device. Cleared on 2026-03-13.
Details
Source
510(k) Clearance
External ID
K260499
Action Date
2026-03-13
Status
Special
Category
device
Product Code
DQY
Product Description
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80. Product code: DQY.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. ABBOTT MEDICAL has received 47 total clearances in our database.
ABBOTT MEDICAL has 86 FDA actions in our database, including 39 recalls and 47 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does ABBOTT MEDICAL have FDA actions?
ABBOTT MEDICAL has 86 FDA actions in our database, including 39 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260499" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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