FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Spur Peripheral Retrievable Stent System
K Number: DEN240048
·
Decision May 29, 2025
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
0
Applicant Total
9
Review Days
251
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Basic Information
- Device Name
- Spur Peripheral Retrievable Stent System
- K Number
- DEN240048
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.5110
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Reflow Medical, Inc.
- Date Received
- September 20, 2024
- Decision Date
- May 29, 2025
- Product Code
- SEU
- 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 |
|---|---|---|---|
| SEU | Peripheral Temporary And Retrievable Stent System | FDA class 2 | Cardiovascular |
Other Clearances by Reflow Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Aug 22, 2025 | Substantially Equivalent |
| 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 |