The following data is part of a premarket notification filed by Ev3 Neurovascular with the FDA for Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315.
| Device ID | K092495 |
| 510k Number | K092495 |
| Device Name: | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Laurie E Cartwright |
| Correspondent | Laurie E Cartwright EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-14 |
| Decision Date | 2009-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462004559 | K092495 | 000 |
| 00836462004542 | K092495 | 000 |