FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoraForce Microcatheter, CoraFlex Microcatheter
K Number: K251277
·
Decision Aug 22, 2025
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
9
Review Days
120
Basic Information
- Device Name
- CoraForce Microcatheter, CoraFlex Microcatheter
- K Number
- K251277
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reflow Medical, Inc.
- Date Received
- April 24, 2025
- Decision Date
- August 22, 2025
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Reflow Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN240048 | Spur Peripheral Retrievable Stent System | May 29, 2025 | Unknown |
| K233350 | SINC Support Catheter | Feb 8, 2024 | Substantially Equivalent |
| K201811 | coraForce and coraFlex Support Catheters | Oct 26, 2020 | Substantially Equivalent |
| K190393 | Wingman 14C Crossing Catheter | May 9, 2019 | Substantially Equivalent |
| K173661 | Wingman 35 Crossing Catheter | Apr 18, 2018 | Substantially Equivalent |
| K173662 | speX Support Catheter | Dec 20, 2017 | Substantially Equivalent |
| K170996 | Wingman 14C Crossing Catheter | Jun 9, 2017 | Substantially Equivalent |
| K160848 | Wingman 18 Crossing Catheter | Jul 14, 2016 | Substantially Equivalent |