PCA-C1 series Patient Cable— 510(k) K200722

Substantially Equivalent

QT Medical, Inc.

FDA 510(k) clearance K200722 for PCA-C1 series Patient Cable, Substantially Equivalent on 2021-06-03. Applicant: QT Medical, Inc..

Clearance details

Applicant: QT Medical, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2020-03-19
Decision date: 2021-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Diamond Bar, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.