Coag-Sense Prothrombin Time (PT) / INR Monitoring Device— 510(k) K183255

Substantially Equivalent

Coagusense, Inc.

FDA 510(k) clearance K183255 for Coag-Sense Prothrombin Time (PT) / INR Monitoring Device, Substantially Equivalent on 2019-02-21. Applicant: Coagusense, Inc..

Clearance details

Applicant: Coagusense, Inc.
Product code: Code GJS
Advisory panel: Hematology
Date received: 2018-11-21
Decision date: 2019-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

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.