RIGHT ATRIAL CATHETER— 510(k) K840742

Substantially Equivalent

The Healthcare Group Laboratories, Inc.

FDA 510(k) clearance K840742 for RIGHT ATRIAL CATHETER, Substantially Equivalent on 1984-07-13. Applicant: The Healthcare Group Laboratories, Inc..

Clearance details

Applicant: The Healthcare Group Laboratories, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1984-02-03
Decision date: 1984-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.