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510(k) Data Aggregation
K Number
K191324Device Name
CivaDerm
Manufacturer
CivaTech Oncology Inc.
Date Cleared
2019-09-20
(127 days)
Product Code
KXK, ONL
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
CivaTech Oncology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CivaDerm™ Pd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment for residual disease after excision of primary or recurrent tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.
Device Description
The CivaDerm utilizes biocompatible materials and bioabsorbable polymers to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaDerm is a planar unidirectional source intended to deliver x-ray radiation for surface brachytherapy procedures. By utilizing gold backing with the radionuclide. CivaDerm provides radiation in one direction. This allows it to target radiation dose to a contoured exterior surface without irradiating surrounding healthy tissue.
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