The following data is part of a premarket notification filed by Biosphere Medical, Inc. with the FDA for Quadrasphere 30 To 60.
| Device ID | K113822 |
| 510k Number | K113822 |
| Device Name: | QUADRASPHERE 30 TO 60 |
| Classification | Device, Neurovascular Embolization |
| Applicant | BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland, MA 02370 |
| Contact | Linda J Varroso |
| Correspondent | Linda J Varroso BIOSPHERE MEDICAL, INC. 1050 HINGHAM ST. Rockland, MA 02370 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-03-08 |
| Summary: | summary |