The following data is part of a premarket notification filed by Precision Vascular Systems, Inc. with the FDA for Pvs 1300 Neuro Guide Wire.
| Device ID | K002907 |
| 510k Number | K002907 |
| Device Name: | PVS 1300 NEURO GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | PRECISION VASCULAR SYSTEMS, INC. 360 WAKARA WAY Salt Lake City, UT 84108 |
| Contact | John R Ragazzo |
| Correspondent | John R Ragazzo PRECISION VASCULAR SYSTEMS, INC. 360 WAKARA WAY Salt Lake City, UT 84108 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-18 |
| Decision Date | 2001-03-08 |