The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Chariot Guiding Sheath.
| Device ID | K150186 |
| 510k Number | K150186 |
| Device Name: | Chariot Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Kurtis Hunsberger |
| Correspondent | Kurtis Hunsberger BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-27 |
| Decision Date | 2015-06-05 |
| Summary: | summary |