510(k) K991549
K991549 is an FDA 510(k) premarket notification submitted by Biosphere Medical for the device "EMBOSPHERE MICROSPHERES". The FDA issued a decision of Substantially Equivalent on April 26, 2000. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Biosphere Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 2000
- Date Received
- May 3, 1999
- 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