510(k) K192480
K192480 is an FDA 510(k) premarket notification submitted by Biosphere Medical, S.A. for the device "Torpedo Gelatin Foam". The FDA issued a decision of Substantially Equivalent on November 21, 2019. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Biosphere Medical, S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2019
- Date Received
- September 10, 2019
- 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