The following data is part of a premarket notification filed by Ev3 Neurovascular with the FDA for Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104.
| Device ID | K091458 |
| 510k Number | K091458 |
| Device Name: | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Tom Daughters |
| Correspondent | Tom Daughters EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-10-15 |
| Summary: | summary |