The following data is part of a premarket notification filed by Precision Vascular Systems, Inc. with the FDA for Pvs 1400 Guide Wite With Hydrophilic Coating.
| Device ID | K002707 |
| 510k Number | K002707 |
| Device Name: | PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING |
| 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 | 2000-08-30 |
| Decision Date | 2000-11-08 |