The following data is part of a premarket notification filed by Piolax Medical Devices, Inc. with the FDA for Piolax Hydrophilic Guidewire.
| Device ID | K980977 |
| 510k Number | K980977 |
| Device Name: | PIOLAX HYDROPHILIC GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | PIOLAX MEDICAL DEVICES, INC. 1800 M ST., N.W. Washington, DC 20036 |
| Contact | Elizabeth Bierman |
| Correspondent | Elizabeth Bierman PIOLAX MEDICAL DEVICES, INC. 1800 M ST., N.W. Washington, DC 20036 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-10-27 |
| Summary: | summary |