The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Spring Coil Guidewire.
| Device ID | K143135 |
| 510k Number | K143135 |
| Device Name: | Spring Coil Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | NeoMetrics, Inc. 2605 Fernbrook Lane, Suite J Plymouth, MN 55447 |
| Contact | Gene Champeau |
| Correspondent | Gene Champeau NeoMetrics, Inc. 2605 Fernbrook Lane, Suite J Plymouth, 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 | 2014-10-31 |
| Decision Date | 2015-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741099356 | K143135 | 000 |
| 10801741099349 | K143135 | 000 |
| 00857834006391 | K143135 | 000 |
| 00857834006063 | K143135 | 000 |
| 00857834006056 | K143135 | 000 |
| 00857834006049 | K143135 | 000 |
| 00857834006032 | K143135 | 000 |