The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Rotablator Rotational Atherectomy System With Peripheral Rotalink Plus.
| Device ID | K121774 |
| 510k Number | K121774 |
| Device Name: | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Beth Torok |
| Correspondent | Beth Torok BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-18 |
| Decision Date | 2012-09-13 |
| Summary: | summary |