The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Hyperform Occlusion Balloon System, Model 104-4470, 104-4471, 104-4770, 104-4771.
| Device ID | K011656 |
| 510k Number | K011656 |
| Device Name: | HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-29 |
| Decision Date | 2001-06-20 |
| Summary: | summary |