The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Introducer Sheath And Dilator.
| Device ID | K971165 |
| 510k Number | K971165 |
| Device Name: | INTRODUCER SHEATH AND DILATOR |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Wanda M Carpinella |
| Correspondent | Wanda M Carpinella BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-07-23 |
| Summary: | summary |