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510(k) Data Aggregation
K Number
K001366Device Name
PROSTEC 125I BRANCHYTHERAPY SNAPSEED
Manufacturer
Date Cleared
2000-09-19
(172 days)
Product Code
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
PROSTEC LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993280Device Name
PROSTEC 125I BRACHYTHERAPY SEEDS
Manufacturer
Date Cleared
2000-03-14
(166 days)
Product Code
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
PROSTEC LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
125I Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
Device Description
The 125I Brachytherapy Seeds consist of 125I absorbed onto the surface of a spherical polymeric substrate sealed in a welded titanium casing. A typical Brachytherapy Seed is shown below. For higher activity levels the number of beads with absorbed 1431 may be increased from 2 to 4.
Typically, the 1351 Brachytherapy Seeds are placed within or in close to the turnor to be treated utilizing guidance. The devices are delivered using an 18 gauge or greater diameter hypodermic needle.
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