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FDA 510(k)

CloudCath Peritoneal Dialysis Drain Set Monitoring System

K-Number: K212658 · 2022-02-09

ApplicantCloudcath
Decision Date2022-02-09
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CloudCath Peritoneal Dialysis Drain Set Monitoring System is a medical device manufactured by Cloudcath. It received FDA 510(k) clearance on 2022-02-09 under approval number K212658. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CloudCath Peritoneal Dialysis Drain Set Monitoring System?

CloudCath Peritoneal Dialysis Drain Set Monitoring System is a medical device that received FDA 510(k) clearance on 2022-02-09. It is manufactured by Cloudcath. The 510(k) number is K212658.

When was CloudCath Peritoneal Dialysis Drain Set Monitoring System approved by the FDA?

CloudCath Peritoneal Dialysis Drain Set Monitoring System received FDA 510(k) clearance on 2022-02-09, under approval number K212658.

What company makes CloudCath Peritoneal Dialysis Drain Set Monitoring System?

CloudCath Peritoneal Dialysis Drain Set Monitoring System is manufactured by Cloudcath.

What is the FDA product code for CloudCath Peritoneal Dialysis Drain Set Monitoring System?

The FDA product code for CloudCath Peritoneal Dialysis Drain Set Monitoring System is FKX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026)

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Official Source

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