ASEPT PLEURAL DRAINAGE SYSTEM— 510(k) K093307

Substantially Equivalent

Pfm Medical, Inc.

FDA 510(k) clearance K093307 for ASEPT PLEURAL DRAINAGE SYSTEM, Substantially Equivalent on 2009-11-06. Applicant: Pfm Medical, Inc..

Clearance details

Applicant: Pfm Medical, Inc.
Product code: Code DWM
Advisory panel: Cardiovascular
Date received: 2009-10-22
Decision date: 2009-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oceanside, CA, US

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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.