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510(k) Data Aggregation
K Number
K982326Device Name
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGYManufacturer
Date Cleared
1999-07-12
(375 days)
Product Code
Regulation Number
876.5540Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Vaxcel Chronic Dialysis Catheter is designed for chronic hemodialysis and apheresis.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a Boston Scientific Vascular (BSV) Chronic Dialysis Catheter, dated July 12, 1999. It does not contain information regarding acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) summary or the premarket submission itself, not the clearance letter.
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