510(k) K180653
K180653 is an FDA 510(k) premarket notification submitted by Spartan Micro, Inc. for the device "Spartan eCoil System". The FDA issued a decision of Substantially Equivalent on Dec 4, 2018. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Spartan Micro, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 4, 2018
- Date Received
- Mar 13, 2018
- 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)