The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Occluder Occlusion Balloon Catheter.
| Device ID | K133750 |
| 510k Number | K133750 |
| Device Name: | OCCLUDER OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Christine Shoemaker |
| Correspondent | Christine Shoemaker Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-01-08 |
| Summary: | summary |