Amplatzer TorqVue Delivery System
FDA 510(k) K260993 · Abbott
510(k) numberK260993
Submission
- Device name
- Amplatzer TorqVue Delivery System
- Applicant
- Abbott
Saint Paul, MN, US - Received
- March 26, 2026
- Decision date
- April 24, 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
Other 510(k)s with product code DQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | Abbott | 07/02/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 04/10/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | Abbott Medical | 03/13/2026SE |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB…DQY · Traditional | Medtronic, Inc. | 12/19/2025SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | 07/02/2026SE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD · Traditional | 09/17/2025SE |
| K233655 | Lingo Glucose SystemSAF · Traditional | 05/29/2024SE |
| K222297 | CentriMag Pre-connected PackDTZ · Traditional | 12/01/2022SE |
| K221213 | EnSite X EP SystemDQK · Traditional | 08/18/2022SE |
| 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 |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | 05/29/2019SE |
| K182981 | Confirm Rx Insertable Cardiac MonitorMXC · Traditional | 03/29/2019SE |
Questions and answers
When was Amplatzer TorqVue Delivery System cleared by the FDA?
Amplatzer TorqVue Delivery System (K260993) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 29 days after the submission was received.
What is the product code of K260993?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.