The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Maxforce Tts Single-use Balloon Dilator.
| Device ID | K061787 |
| 510k Number | K061787 |
| Device Name: | MAXFORCE TTS SINGLE-USE BALLOON DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Wing Ng |
| Correspondent | Wing Ng BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-09-21 |
| Summary: | summary |