The following data is part of a premarket notification filed by Precision Vascular Systems, Inc. with the FDA for Pvs 1400 Guidewire.
| Device ID | K990823 |
| 510k Number | K990823 |
| Device Name: | PVS 1400 GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | PRECISION VASCULAR SYSTEMS, INC. 360 WAKARA WAY Salt Lake City, UT 84108 |
| Contact | John Ragazzo |
| Correspondent | John 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 | 1999-03-12 |
| Decision Date | 1999-07-23 |
| Summary: | summary |