K103008 is an FDA 510(k) clearance for the INZONE DETACHMENT SYSTEM. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on December 10, 2010, 59 days after receiving the submission on October 12, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K103008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 2010 |
| Decision Date | December 10, 2010 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCG — Device, Neurovascular Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5950 |