The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Encore 26 Advantage Kit.
| Device ID | K123214 |
| 510k Number | K123214 |
| Device Name: | ENCORE 26 ADVANTAGE KIT |
| Classification | Syringe, Balloon Inflation |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Rachel Owens |
| Correspondent | Rachel Owens BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2012-11-13 |
| Summary: | summary |