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Found 4 results
510(k) Data Aggregation
K Number
K062241Device Name
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
Manufacturer
NORTH AMERICAN SCIENTIFIC, INC.
Date Cleared
2006-11-09
(99 days)
Product Code
JAQ
Regulation Number
892.5700Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Adjustable Multi-Catheter Source Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy of breast cancer.
Device Description
Not Found
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K Number
K060679Device Name
SURTRAK IMPLANTATION KIT
Manufacturer
NORTH AMERICAN SCIENTIFIC, INC.
Date Cleared
2006-04-21
(37 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used either as primary treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable turnors or for residual disease after excision of the primary turnor. North American Scientific Brachytherapy Preloaded Needle Kit implants are indicated for use with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Device Description
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K Number
K052024Device Name
NSTRAND IMPLANTATION KIT
Manufacturer
NORTH AMERICAN SCIENTIFIC, INC.
Date Cleared
2005-09-07
(43 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The North American Scientific, Inc Brachytherapy Preloaded Needle Kit is indicated for interstitial implantation of select localized tumors with low to medium radiosensitivity. They are used primarily for treatment for tumors such as those in the head, neck, lung, pancreas, breast, cervix and prostate and unresectable tumors or for residual disease after excision of the primary tumor. Preloaded implants are used with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.
Device Description
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K Number
K964647Device Name
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
Manufacturer
NORTH AMERICAN SCIENTIFIC, INC.
Date Cleared
1997-02-10
(82 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
NORTH AMERICAN SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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