Amplatzer TorqVue Exchange System
FDA 510(k) K261631 · Abbott Medical
510(k) numberK261631
Submission
- Device name
- Amplatzer TorqVue Exchange System
- Applicant
- Abbott Medical
Saint Paul, MN, US - Received
- May 18, 2026
- Decision date
- June 17, 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 |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | Abbott | 04/24/2026SE |
| 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 |
|---|---|---|
| K262006 | EnSite X EP SystemDQK · Special | 07/15/2026SE |
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | 04/24/2026SE |
| K260212 | EnSite X EP SystemDQK · Traditional | 04/20/2026SE |
| K253907 | Disposable Radiofrequency CannulaGXI · Traditional | 04/16/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | 03/13/2026SE |
| K252512 | Armada 14 NC PTA CatheterLIT · Traditional | 02/13/2026SE |
| K253516 | Assert-IQ (DM5100)MXD · Special | 12/18/2025SE |
| K252417 | Amplatzer Piccolo Delivery System (9-PDS-04F-045)DQY · Traditional | 12/17/2025SE |
| K253232 | Seguin Annuloplasty RingKRH · Special | 10/29/2025SE |
| K250031 | Amplatzer GuidewireDQX · Traditional | 10/03/2025SE |
Questions and answers
When was Amplatzer TorqVue Exchange System cleared by the FDA?
Amplatzer TorqVue Exchange System (K261631) received a 510(k) decision of Substantially Equivalent on June 17, 2026, 30 days after the submission was received.
What is the product code of K261631?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.