510(k) DEN230064
DEN230064 is an FDA 510(k) premarket notification submitted by Rapid Medical Ltd. for the device "BraidE Embolization Assist Device". The FDA issued a decision of De Novo Granted on February 21, 2024. The device falls under product code QZU (Temporary Embolization Assist Device, Peripheral), a Class II device regulated under 21 CFR 870.3325. Rapid Medical Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 21, 2024
- Date Received
- September 19, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Embolization Assist Device, Peripheral
- Device Class
- Class II
- Regulation Number
- 870.3325
- Review Panel
- CV
- Submission Type
A temporary coil embolization assist device is a prescription device intended for temporary use in the vasculature to mechanically assist in the embolization of aneurysms with embolic coils. The device is delivered into the vasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.