K251828

Substantially Equivalent

CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set

Applicant
Cerenovus, Inc.
Product code
NRY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Miami, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code NRY

product code NRY
Death
411
Injury
1,712
Malfunction
1,855
Total
3,978

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.