The following data is part of a premarket notification filed by Scion Cardio-vascular, Inc. with the FDA for M-bolus Embolic Microspheres.
| Device ID | K052509 |
| 510k Number | K052509 |
| Device Name: | M-BOLUS EMBOLIC MICROSPHERES |
| Classification | Device, Neurovascular Embolization |
| Applicant | SCION CARDIO-VASCULAR, INC. 14256 SW 119TH AVE. Miami, FL 33186 |
| Contact | Suzana Otano-lata |
| Correspondent | Suzana Otano-lata SCION CARDIO-VASCULAR, INC. 14256 SW 119TH AVE. Miami, FL 33186 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-13 |
| Decision Date | 2006-12-11 |
| Summary: | summary |