510(k) K113822
K113822 is an FDA 510(k) premarket notification submitted by Biosphere Medical, Inc. for the device "QUADRASPHERE 30 TO 60". The FDA issued a decision of Substantially Equivalent on March 8, 2012. The device falls under product code HCG (Device, Neurovascular Embolization), a Class II device regulated under 21 CFR 882.5950. Biosphere Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2012
- Date Received
- December 27, 2011
- Clearance Type
- Special
- 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