DeviceClearance

K121774

Substantially Equivalent

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS

Applicant
Boston Scientific Corp
Product code
MCW
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Maple Grove, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MCW

product code MCW
Death
38
Injury
1,386
Malfunction
2,676
Other
2
Total
4,102

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.