The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Rigiflex Single-use Achalasia Balloon Dilator.
| Device ID | K050232 |
| 510k Number | K050232 |
| Device Name: | RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR |
| Classification | Esophageal Dilator Balloon With Or Without Electrode Sensors |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | Paige Sweeney |
| Correspondent | Paige Sweeney BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | PID |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-01 |
| Decision Date | 2005-03-11 |
| Summary: | summary |