The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Equinox Occlusion Balloon System.
| Device ID | K990487 |
| 510k Number | K990487 |
| Device Name: | EQUINOX OCCLUSION BALLOON SYSTEM |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Tom Daughters |
| Correspondent | Tom Daughters MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-16 |
| Decision Date | 1999-08-31 |
| Summary: | summary |