510(k) K863482— DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE

Substantially Equivalent

Cardio Metrics, Inc.

Clearance details

Applicant: Cardio Metrics, Inc.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1986-09-09
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.