510(k) K182390
K182390 is an FDA 510(k) premarket notification submitted by Shape Memory Medical for the device "IMPEDE-FX Embolization Plug". The FDA issued a decision of Substantially Equivalent on May 23, 2019. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Shape Memory Medical has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2019
- Date Received
- Sep 4, 2018
- Clearance Type
- Traditional
- 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)