510(k) K896127— THORA-KLEX CHEST DRAINAGE UNIT

Substantially Equivalent

Davol, Inc.

Clearance details

Applicant
Davol, Inc.
Product code
Code KDQ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cranston, RI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KDQ

product code KDQ
Death
8
Malfunction
637
Total
645

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.