1.4 FR MAPCATH SENSOR STYLET— 510(k) K973057

Substantially Equivalent

Navion Biomedical Corp.

FDA 510(k) clearance K973057 for 1.4 FR MAPCATH SENSOR STYLET, Substantially Equivalent on 1997-11-12. Applicant: Navion Biomedical Corp..

Clearance details

Applicant: Navion Biomedical Corp.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1997-08-15
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, 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.