The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Equinox Occulsion Balloon System Model # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026.
| Device ID | K010162 |
| 510k Number | K010162 |
| Device Name: | EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026 |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon MICRO THERAPEUTICS, INC. 2 GOODYEAR 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 | 2001-01-17 |
| Decision Date | 2001-05-18 |