510(k) K142513
K142513 is an FDA 510(k) premarket notification submitted by Blockade Medical for the device "Barricade Embolization Coil System". The FDA issued a decision of Substantially Equivalent on November 13, 2014. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Blockade Medical has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2014
- Date Received
- September 8, 2014
- Clearance Type
- Special
- 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