The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Cre(tm) Balloon Dilatation Catheter.
| Device ID | K974788 |
| 510k Number | K974788 |
| Device Name: | CRE(TM) BALLOON DILATATION CATHETER |
| Classification | Dilator, Esophageal |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Daniel J Dillion |
| Correspondent | Daniel J Dillion BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-03-20 |
| Summary: | summary |