The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Transend Ex Platinum Guidewire.
| Device ID | K971254 |
| 510k Number | K971254 |
| Device Name: | TRANSEND EX PLATINUM GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Mary P Legraw |
| Correspondent | Mary P Legraw BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-03 |
| Decision Date | 1997-07-01 |
| Summary: | summary |