Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
Device Facts
| Record ID | K261825 |
|---|---|
| Device Name | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter |
| Applicant | Abbott |
| Product Code | DQY · Cardiovascular |
| Decision Date | Jul 2, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
