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510(k) Data Aggregation
K Number
K083370Manufacturer
Date Cleared
2008-12-12
(28 days)
Regulation Number
870.5150Type
SpecialPanel
CardiovascularReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
For breaking apart and removing thrombus from hemodialysis access grafts.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for the D-Clot Thrombectomy Catheter System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter merely states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text. The document does not describe:
- Acceptance criteria and reported device performance
- Sample size used, data provenance
- Number of experts or their qualifications
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone performance
- Type of ground truth used
- Sample size for training set
- How ground truth for the training set was established
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