The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Choice Guide Wire, Mailman Guide Wire, Luge Guide Wire, Choice Pt Guide Wire, Pt Graphix Wire.
| Device ID | K143587 |
| 510k Number | K143587 |
| Device Name: | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Nikki M Wahlberg |
| Correspondent | Nikki M Wahlberg BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-18 |
| Decision Date | 2015-01-15 |
| Summary: | summary |