Amplatzer TorqVue Exchange System— 510(k) K261631
Substantially EquivalentAbbott Medical
FDA 510(k) clearance K261631 for Amplatzer TorqVue Exchange System, Substantially Equivalent on 2026-06-17. Applicant: Abbott Medical. Device class: 2.
Summary
Abbott Medical's Amplatzer TorqVue Exchange System is filed under DQY, percutaneous catheters. The record gives no sizes or components.
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel. It was a Special 510(k).
Abbott filed from Saint Paul, Minnesota. Review took 30 calendar days (May 18 to June 17, 2026).
Clearance details
- Applicant
- Abbott Medical
- 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
Recent devices under product code DQY
view allMore clearances from Abbott Medical
view allAdverse 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.