The following data is part of a premarket notification filed by Micro Therapeutics Dba Ev3 Neurovascular with the FDA for Hyperglide And Hyperform Occlusion Balloon Systems.
| Device ID | K101570 |
| 510k Number | K101570 |
| Device Name: | HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine, CA 92618 |
| Contact | Laurie Cartwright |
| Correspondent | Laurie Cartwright MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY 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 | 2010-06-04 |
| Decision Date | 2010-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000294144 | K101570 | 000 |
| 00763000294502 | K101570 | 000 |
| 00763000294533 | K101570 | 000 |
| 00763000294564 | K101570 | 000 |
| 00763000294595 | K101570 | 000 |
| 00847536004863 | K101570 | 000 |
| 00847536004948 | K101570 | 000 |
| 00847536004986 | K101570 | 000 |
| 00847536005020 | K101570 | 000 |
| 00763000294472 | K101570 | 000 |
| 00763000294441 | K101570 | 000 |
| 00763000294410 | K101570 | 000 |
| 00763000294175 | K101570 | 000 |
| 00763000294205 | K101570 | 000 |
| 00763000294236 | K101570 | 000 |
| 00763000294267 | K101570 | 000 |
| 00763000294298 | K101570 | 000 |
| 00763000294328 | K101570 | 000 |
| 00763000294359 | K101570 | 000 |
| 00763000294380 | K101570 | 000 |
| 00847536005075 | K101570 | 000 |
| 00847536005105 | K101570 | 000 |
| 00847536005143 | K101570 | 000 |
| 00847536005587 | K101570 | 000 |
| 00847536005617 | K101570 | 000 |
| 00847536005648 | K101570 | 000 |
| 00847536005679 | K101570 | 000 |
| 00847536005709 | K101570 | 000 |
| 00847536005730 | K101570 | 000 |
| 00847536005792 | K101570 | 000 |
| 00847536005822 | K101570 | 000 |
| 00847536005549 | K101570 | 000 |
| 00847536005501 | K101570 | 000 |
| 00847536005471 | K101570 | 000 |
| 00847536005174 | K101570 | 000 |
| 00847536005204 | K101570 | 000 |
| 00847536005235 | K101570 | 000 |
| 00847536005266 | K101570 | 000 |
| 00847536005297 | K101570 | 000 |
| 00847536005327 | K101570 | 000 |
| 00847536005358 | K101570 | 000 |
| 00847536005419 | K101570 | 000 |
| 00847536005853 | K101570 | 000 |