The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Hi-torque Sport-t(tm) Guide Wire.
| Device ID | K915554 |
| 510k Number | K915554 |
| Device Name: | HI-TORQUE SPORT-T(TM) GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Beverly A Huss |
| Correspondent | Beverly A Huss 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 | 1991-12-11 |
| Decision Date | 1993-02-09 |