The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Equinox Occlusion Balloon Catheter/system - (10mm Balloon, 4 & 13 Mm Tip), (15 Mm Balloon, 4 & 13 Mm Tip), (20 Mm Balloo.
| Device ID | K001237 |
| 510k Number | K001237 |
| Device Name: | EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO |
| 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 (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-18 |
| Decision Date | 2000-05-18 |