FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
BraidE Embolization Assist Device
K Number: DEN230064
·
Decision Feb 21, 2024
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
6
Review Days
155
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Basic Information
- Device Name
- BraidE Embolization Assist Device
- K Number
- DEN230064
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.3325
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Rapid Medical , Ltd.
- Date Received
- September 19, 2023
- Decision Date
- February 21, 2024
- Product Code
- QZU
- 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 |
|---|---|---|---|
| QZU | Temporary Embolization Assist Device, Peripheral | FDA class 2 | Cardiovascular |
Other Clearances by Rapid Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253062 | Tigertriever 25 Revascularization Device | Mar 12, 2026 | Substantially Equivalent |
| K251603 | Tigertriever 17 Ultra Revascularization Device | Oct 6, 2025 | Substantially Equivalent |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device | Apr 17, 2023 | Substantially Equivalent |
| K220808 | Tigertriever 13 Revascularization Device | Jul 25, 2022 | Substantially Equivalent |
| K203592 | Tigertriever and Tigertriever 17 Revascularization Devce | Mar 23, 2021 | Substantially Equivalent |