510(k) K220699
K220699 is an FDA 510(k) premarket notification submitted by Bait USA, LLC for the device "Prestige Coil System". The FDA issued a decision of Substantially Equivalent on Apr 8, 2022. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 8, 2022
- Date Received
- Mar 10, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vascular, For Promoting Embolization
- Device Class
- Class II
- Regulation Number
- 870.3300
- Review Panel
- CV
- Submission Type
- 510(k)