Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
FDA 510(k) K261825 · Abbott
510(k) numberK261825
Submission
- Device name
- Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
- Applicant
- Abbott
Saint Paul, MN, US - Received
- June 2, 2026
- Decision date
- July 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K212061 | EnSite X EP SystemDQK · Traditional | 10/22/2021SE |
| K210392 | WorkMate Claris SystemDQK · Special | 03/11/2021SE |
| K192593 | Confirm Rx Insertable Cardiac MonitorMXC · Special | 10/18/2019SE |
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| K182981 | Confirm Rx Insertable Cardiac MonitorMXC · Traditional | 03/29/2019SE |
Questions and answers
When was Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter cleared by the FDA?
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825) received a 510(k) decision of Substantially Equivalent on July 2, 2026, 30 days after the submission was received.
What is the product code of K261825?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.