510(k) DEN170064
DEN170064 is an FDA 510(k) premarket notification submitted by Rapid-Medical , Ltd. for the device "Comaneci, Comaneci Petit, Comaneci 17". The FDA issued a decision of De Novo Granted on April 24, 2019. The device falls under product code PUU (Temporary Coil Embolization Assist Device), a Class II device regulated under 21 CFR 882.5955. Rapid-Medical , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 24, 2019
- Date Received
- September 28, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporary Coil Embolization Assist Device
- Device Class
- Class II
- Regulation Number
- 882.5955
- Review Panel
- NE
- Submission Type
A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.