510(k) K230284
K230284 is an FDA 510(k) premarket notification submitted by Penumbra, Inc. for the device "Penumbra LP Coil System". The FDA issued a decision of Substantially Equivalent on October 25, 2023. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Penumbra, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2023
- Date Received
- February 2, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Neurovascular Embolization
- Device Class
- Class II
- Regulation Number
- 882.5950
- Review Panel
- NE
- Submission Type