DeviceClearance

K951089

Substantially Equivalent

SCIMED GATEWAY PLUS

Applicant
Scimed Life Systems, Inc.
Product code
DTL
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 DTL

product code DTL
Malfunction
770
Total
770

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.