PLEURA-GARD ATS— 510(k) K871568

Substantially Equivalent

Conmedcorp

FDA 510(k) clearance K871568 for PLEURA-GARD ATS, Substantially Equivalent on 1987-06-22. Applicant: Conmedcorp.

Clearance details

Applicant: Conmedcorp
Product code: Code CAC
Advisory panel: Anesthesiology
Date received: 1987-04-22
Decision date: 1987-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Utica, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAC

product code CAC

Death: 11
Malfunction: 477
Total: 488

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.