The following data is part of a premarket notification filed by Precision Vascular Systems, Inc. with the FDA for Pvs 1600 Synchro 0.010 Neuro Guide Wire.
| Device ID | K023700 |
| 510k Number | K023700 |
| Device Name: | PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | PRECISION VASCULAR SYSTEMS, INC. 2405 WEST ORTON CIR. West Valley City, UT 84119 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski PRECISION VASCULAR SYSTEMS, INC. 2405 WEST ORTON CIR. West Valley City, UT 84119 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-04 |
| Decision Date | 2002-12-04 |
| Summary: | summary |