Ev3, Inc. · Class II · Cleared Feb 2, 2010
| K-number | K100063 |
| Device name | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL |
| Applicant | Ev3, Inc. |
| Product code | MJN |
| Device class | Class II |
| Decision date | Feb 2, 2010 |
| Decision | Substantially Equivalent |
| Regulation | 870.4450 |
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