510(k) K172390
K172390 is an FDA 510(k) premarket notification submitted by Blockade Medical, LLC (D.B.A. Balt Usa) for the device "Optima Coil System". The FDA issued a decision of Substantially Equivalent on Feb 18, 2018. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 18, 2018
- Date Received
- Aug 8, 2017
- 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
- 510(k)