K071634 is an FDA 510(k) clearance for the MODIFICATION TO:CONTOUR SE MICROSPHERES. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on July 12, 2007, 27 days after receiving the submission on June 15, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K071634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2007 |
| Decision Date | July 12, 2007 |
| Days to Decision | 27 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 |