The following data is part of a premarket notification filed by Microvena Corp. with the FDA for The Amplantz Goose Neck Microsnare.
| Device ID | K970668 |
| 510k Number | K970668 |
| Device Name: | THE AMPLANTZ GOOSE NECK MICROSNARE |
| Classification | Catheter, Percutaneous |
| Applicant | MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Contact | Karen Bannick |
| Correspondent | Karen Bannick MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-24 |
| Decision Date | 1998-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684005057 | K970668 | 000 |
| 00763000762452 | K970668 | 000 |
| 00763000762469 | K970668 | 000 |
| 00763000762476 | K970668 | 000 |
| 00763000762483 | K970668 | 000 |
| 00763000762490 | K970668 | 000 |
| 00763000225377 | K970668 | 000 |
| 00763000225384 | K970668 | 000 |
| 00763000225391 | K970668 | 000 |
| 00763000225407 | K970668 | 000 |
| 00763000225414 | K970668 | 000 |
| 00763000225421 | K970668 | 000 |
| 00821684005019 | K970668 | 000 |
| 00821684005026 | K970668 | 000 |
| 00821684005040 | K970668 | 000 |
| 00763000762445 | K970668 | 000 |