The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Hyperform Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter, Hyperglide Occlusion Balloon Catheter Model.
| Device ID | K100063 |
| 510k Number | K100063 |
| Device Name: | HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | EV3 INC 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Laura Heaton |
| Correspondent | Laura Heaton 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 | 2010-01-11 |
| Decision Date | 2010-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536005761 | K100063 | 000 |