The following data is part of a premarket notification filed by Neo Metrics, Inc. with the FDA for Selectiva Sb Guidewire.
| Device ID | K033321 |
| 510k Number | K033321 |
| Device Name: | SELECTIVA SB GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | NEO METRICS, INC. 14800 28TH AVENUE NORTH SUITE 150 Plymouth, MN 55447 |
| Contact | Mark Pederson |
| Correspondent | Mark Pederson NEO METRICS, INC. 14800 28TH AVENUE NORTH SUITE 150 Plymouth, MN 55447 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-15 |
| Decision Date | 2003-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857834006827 | K033321 | 000 |
| 00857834006810 | K033321 | 000 |
| 00857834006803 | K033321 | 000 |
| 00857834006797 | K033321 | 000 |
| 00857834006780 | K033321 | 000 |
| 00857834006773 | K033321 | 000 |
| 00857834006766 | K033321 | 000 |
| 00857834006759 | K033321 | 000 |