CoraForce Microcatheter, CoraFlex Microcatheter
FDA 510(k) K251277 · Reflow Medical, Inc.
510(k) numberK251277
Submission
- Device name
- CoraForce Microcatheter, CoraFlex Microcatheter
- Applicant
- Reflow Medical, Inc.
San Clemente, CA, US - Received
- April 24, 2025
- Decision date
- August 22, 2025
- 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 |
| 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 |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K262013 | Kiba CTO Crossing CatheterPDU · Special | 08/28/2026SE |
| K233350 | SINC Support CatheterDQY · Traditional | 02/08/2024SE |
| K210188 | coraCrossDQY · Special | 05/28/2021SE |
| K201811 | coraForce and coraFlex Support CathetersDQY · Traditional | 10/26/2020SE |
| K200094 | speX LP Support CatheterDQY · Special | 03/18/2020SE |
| K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35DQY · Traditional | 02/20/2020SE |
| K193012 | speX Support CatheterDQY · Traditional | 02/19/2020SE |
| K190393 | Wingman 14C Crossing CatheterDQY · Special | 05/09/2019SE |
| K173661 | Wingman 35 Crossing CatheterDQY · Traditional | 04/18/2018SE |
| K173662 | speX Support CatheterDQY · Special | 12/20/2017SE |
Questions and answers
When was CoraForce Microcatheter, CoraFlex Microcatheter cleared by the FDA?
CoraForce Microcatheter, CoraFlex Microcatheter (K251277) received a 510(k) decision of Substantially Equivalent on August 22, 2025, 120 days after the submission was received.
What is the product code of K251277?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.