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510(k) Data Aggregation
K Number
K973328Device Name
INTERSOURCE
Manufacturer
INTERNATIONAL BRACHYTHERAPY, SA
Date Cleared
1998-12-10
(462 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL BRACHYTHERAPY, SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterSeed™ implants are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. InterSeed™ implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy.
Device Description
InterSeed™ is an hermetically sealed radiotherapeutic source indicated for interstitial implantation. The radionuclide used in InterSeed™ is Palladium 103 (Pd-103). InterSeed™ is constructed by placing a platinum radiopaque marker and Pd-103 on the surface of a medical grade titanium inner tube. The device is sealed by sliding an outer tube, also medical grade titanium, over the inner tube and laser welding both ends. The resulting device has a hollow center with an inner diameter of 0.35 mm with all body tissue contacting surfaces made from medical grade titanium.
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