The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Xxl Vascular Balloon Dilatation Catheter.
| Device ID | K150303 |
| 510k Number | K150303 |
| Device Name: | XXL Vascular Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Melanie Raska |
| Correspondent | Melanie Raska BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-06 |
| Decision Date | 2015-06-15 |
| Summary: | summary |