K110409

Substantially Equivalent

ASPIRA PLEURAL DRAINAGE SYSTEM

Applicant: C.R. Bard, Inc.
Product code: DWM
Advisory panel: Cardiovascular
Date received: 2011-02-14
Decision date: 2011-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake Ciy,, UT, US

Adverse events under product code DWM

product code DWM

Death: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.