The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Coaxial Dilator Set.
| Device ID | K974640 |
| 510k Number | K974640 |
| Device Name: | COAXIAL DILATOR SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Wanda Carpinella |
| Correspondent | Wanda Carpinella BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M001459941 | K974640 | 000 |
| M001459931 | K974640 | 000 |
| M001459921 | K974640 | 000 |
| M001459881 | K974640 | 000 |
| M001459871 | K974640 | 000 |
| M001459861 | K974640 | 000 |
| M001459821 | K974640 | 000 |
| M001459811 | K974640 | 000 |
| M001459801 | K974640 | 000 |