The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Psg Directional Hydrophilic Guide Wire.
| Device ID | K931327 |
| 510k Number | K931327 |
| Device Name: | PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Linda T Guthrie |
| Correspondent | Linda T Guthrie PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-16 |
| Decision Date | 1993-07-14 |