SARNS VENT CATHETER— 510(k) K890024

Substantially Equivalent

3M Company

FDA 510(k) clearance K890024 for SARNS VENT CATHETER, Substantially Equivalent on 1989-03-02. Applicant: 3M Company.

Clearance details

Applicant
3M Company
Product code
Code DWF
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DWF

product code DWF
Death
106
Injury
386
Malfunction
2,323
Total
2,815

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.