DeviceClearance

Amplatzer TorqVue Delivery System— 510(k) K260993

Substantially Equivalent

Abbott

FDA 510(k) clearance K260993 for Amplatzer TorqVue Delivery System, Substantially Equivalent on 2026-04-24. Applicant: Abbott. Device class: 2.

Summary

Abbott's Amplatzer TorqVue Delivery System is filed under product code DQY (Catheter, Percutaneous).

Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).

Abbott filed from Saint Paul, Minnesota. The decision came 29 calendar days after FDA received it (March 26 to April 24, 2026).

Clearance details

Applicant
Abbott
Product code
Product code DQY
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Saint Paul, MN, US
Download summary PDFView on FDA.gov ↗

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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, through . 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.