DRESSING CHANGE KIT— 510(k) K900665

Substantially Equivalent for Some Indications

Healthdyne Cardiovascular, Inc.

FDA 510(k) clearance K900665 for DRESSING CHANGE KIT, Substantially Equivalent for Some Indications on 1990-05-14. Applicant: Healthdyne Cardiovascular, Inc..

Clearance details

Applicant: Healthdyne Cardiovascular, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1990-02-13
Decision date: 1990-05-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.