The following data is part of a premarket notification filed by Boston Scientific - Precision Vascular with the FDA for Pv 1900 Synchro 0.016 Guidewire.
| Device ID | K050964 |
| 510k Number | K050964 |
| Device Name: | PV 1900 SYNCHRO 0.016 GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | BOSTON SCIENTIFIC - PRECISION VASCULAR 2405 WEST ORTON CIR. West Valley City, UT 84119 |
| Contact | Rick Gaykowski |
| Correspondent | Rick Gaykowski BOSTON SCIENTIFIC - PRECISION VASCULAR 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 | 2005-04-18 |
| Decision Date | 2005-06-13 |
| Summary: | summary |