DeviceClearance

K891572

Substantially Equivalent

ANGIOGRAPHY CUSTOM PACKS

Applicant
Procedure Packs, Inc.
Product code
DTL
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Scottsdale, AZ, 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.