THORA-DRAIN III PLASTIC DRAINAGE SYSTEM— 510(k) K801221

Substantially Equivalent

Chesebrough-Pond'S U.S.A. Co.

FDA 510(k) clearance K801221 for THORA-DRAIN III PLASTIC DRAINAGE SYSTEM, Substantially Equivalent on 1980-06-09. Applicant: Chesebrough-Pond'S U.S.A. Co..

Clearance details

Applicant
Chesebrough-Pond'S U.S.A. Co.
Product code
Code KDQ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, 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.