K111451 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on September 20, 2011, 118 days after receiving the submission on May 25, 2011.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K111451 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2011 |
| Decision Date | September 20, 2011 |
| Days to Decision | 118 days |
| Submission Type | Traditional |
| 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 |