The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Cre Fixed Wire Ballon Dilation Catheter.
| Device ID | K122924 |
| 510k Number | K122924 |
| Device Name: | CRE FIXED WIRE BALLON DILATION CATHETER |
| Classification | Dilator, Esophageal |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Janis F Taranto |
| Correspondent | Janis F Taranto BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2012-10-24 |
| Summary: | summary |