The following data is part of a premarket notification filed by Boston Scientific - Precision Vascular with the FDA for Pvs 2000 Synchro2 Guidewire.
| Device ID | K053268 |
| 510k Number | K053268 |
| Device Name: | PVS 2000 SYNCHRO2 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 | 2005-11-23 |
| Decision Date | 2006-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540688798 | K053268 | 000 |
| 04546540688781 | K053268 | 000 |
| 04546540688774 | K053268 | 000 |
| 04546540688767 | K053268 | 000 |
| 04546540688750 | K053268 | 000 |
| 04546540688743 | K053268 | 000 |
| 04546540688736 | K053268 | 000 |
| 04546540688729 | K053268 | 000 |