The following data is part of a premarket notification filed by Concert Medical, Llc with the FDA for Conductor Coronary Guidewire.
| Device ID | K090193 |
| 510k Number | K090193 |
| Device Name: | CONDUCTOR CORONARY GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | CONCERT MEDICAL, LLC 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau CONCERT MEDICAL, LLC 5 WHITCOMB AVENUE Ayer, MA 01432 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-27 |
| Decision Date | 2009-09-25 |
| Summary: | summary |