The following data is part of a premarket notification filed by Ev3 Inc. with the FDA for Hyperglide Occlusion Balloon System.
| Device ID | K090728 |
| 510k Number | K090728 |
| Device Name: | HYPERGLIDE OCCLUSION BALLOON SYSTEM |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | EV3 INC. 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Jason K Lyon |
| Correspondent | Jason K Lyon EV3 INC. 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 | 2009-03-19 |
| Decision Date | 2009-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00836462004580 | K090728 | 000 |
| 00836462004481 | K090728 | 000 |
| 00836462004467 | K090728 | 000 |