DeviceClearance

K080621

Substantially Equivalent

FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01

Applicant
European Custom Manufacturing BV
Product code
DSA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Claremont, NH, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA
Death
2
Total
2

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.