K261825
- 510(k) number
- K261825
- Device name
- Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
- Applicant
- Abbott MN · US
- Product code
- DQY — Catheter, Percutaneous
- Decision date
- 2026-07-02
- Date received
- 2026-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K261825.pdf
Official FDA record: K261825
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.