APRO 35 Swift Catheter
FDA 510(k) K262392 · Alembic, LLC
510(k) numberK262392
Submission
- Device name
- APRO 35 Swift Catheter
- Applicant
- Alembic, LLC
Mountain View, CA, US - Received
- July 14, 2026
- Decision date
- August 12, 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 |
| 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 |
| 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 |
|---|---|---|
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | 08/12/2026SE |
| K251014 | APRO 45 CatheterDQY · Special | 05/01/2025SE |
| K251015 | APRO 45 Catheter and Alembic Aspiration TubingNRY · Special | 04/30/2025SE |
| K250962 | APRO 55 Intermediate CatheterDQY · Special | 04/29/2025SE |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration TubingNRY · Special | 04/28/2025SE |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration TubingNRY · Traditional | 02/24/2025SE |
| K243297 | APRO 70 Swift CatheterQJP · Special | 01/14/2025SE |
| K234115 | APRO 55 CatheterDQY · Traditional | 03/15/2024SE |
| K232971 | APRO 55 Catheter and Alembic Aspiration TubingNRY · Traditional | 02/29/2024SE |
| K230695 | APRO 70 Catheter and Alembic Aspiration TubingNRY · Special | 04/10/2023SE |
Questions and answers
When was APRO 35 Swift Catheter cleared by the FDA?
APRO 35 Swift Catheter (K262392) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 29 days after the submission was received.
What is the product code of K262392?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.