The following data is part of a premarket notification filed by Neo Metrics, Inc. with the FDA for Selectiva Guidewire.
| Device ID | K013024 |
| 510k Number | K013024 |
| Device Name: | SELECTIVA GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | NEO METRICS, INC. 15301 HIGHWAY 55 WEST Minneapolis, MN 55447 |
| Contact | Gene Champeau |
| Correspondent | Gene Champeau NEO METRICS, INC. 15301 HIGHWAY 55 WEST Minneapolis, MN 55447 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-07 |
| Decision Date | 2001-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787058001015 | K013024 | 000 |
| H787058001155 | K013024 | 000 |
| H787058001165 | K013024 | 000 |
| H787058001175 | K013024 | 000 |
| H787058001195 | K013024 | 000 |
| H787058001205 | K013024 | 000 |
| H787058001215 | K013024 | 000 |
| H787058001225 | K013024 | 000 |
| H787058001235 | K013024 | 000 |
| H787058001245 | K013024 | 000 |
| H787058001255 | K013024 | 000 |
| H787058001145 | K013024 | 000 |
| H787058001135 | K013024 | 000 |
| H787058001125 | K013024 | 000 |
| H787058001025 | K013024 | 000 |
| H787058001035 | K013024 | 000 |
| H787058001045 | K013024 | 000 |
| H787058001055 | K013024 | 000 |
| H787058001065 | K013024 | 000 |
| H787058001075 | K013024 | 000 |
| H787058001085 | K013024 | 000 |
| H787058001095 | K013024 | 000 |
| H787058001105 | K013024 | 000 |
| H787058001115 | K013024 | 000 |
| H787058001265 | K013024 | 000 |
| H787058001275 | K013024 | 000 |
| H787058001285 | K013024 | 000 |
| 00857834006704 | K013024 | 000 |
| 00857834006711 | K013024 | 000 |
| 00857834006728 | K013024 | 000 |
| 00857834006834 | K013024 | 000 |
| 00857834006841 | K013024 | 000 |
| 00857834006858 | K013024 | 000 |
| 00857834006865 | K013024 | 000 |
| 00857834006872 | K013024 | 000 |
| 00857834006889 | K013024 | 000 |
| 00857834006896 | K013024 | 000 |
| 00857834006698 | K013024 | 000 |
| 00857834006681 | K013024 | 000 |
| 00857834006674 | K013024 | 000 |
| H787058001295 | K013024 | 000 |
| 00857834006575 | K013024 | 000 |
| 00857834006582 | K013024 | 000 |
| 00857834006599 | K013024 | 000 |
| 00857834006612 | K013024 | 000 |
| 00857834006629 | K013024 | 000 |
| 00857834006636 | K013024 | 000 |
| 00857834006643 | K013024 | 000 |
| 00857834006650 | K013024 | 000 |
| 00857834006667 | K013024 | 000 |
| 00857834006902 | K013024 | 000 |