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Found 15 results
510(k) Data Aggregation
K Number
K062214Device Name
BRACHYSCIENCES STRANDPORT
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
2007-03-01
(212 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The World Wide Medical Technologies StrandPort intended use is to provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures.
Device Description
disposable carrier for seed strands containing radionuclide seeds
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K Number
K023179Device Name
READI-STRAND, MODEL PSSTRAND
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
2003-07-02
(281 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.
Device Description
Not Found
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K Number
K022705Device Name
READI-STRAND, MODEL PSSTRAND
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
2003-06-09
(299 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures.
Device Description
Not Found
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K Number
K022389Device Name
READI-LOAD SYSTEM, MODEL PSS 1820RL
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
2003-05-06
(287 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Worldwide Medical Technologies Readi-Load intended use is to provide a pre-sterilized needle carrier for radionuclide seeds for the introduction of radionuclide seeds into the body for Brachytherapy procedures.
Device Description
Not Found
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K Number
K020641Device Name
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
2002-10-29
(244 days)
Product Code
BZD
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spiritus™ Respiratory System is a patient interface accessory intended for use with devices that administer CPAP (continuous positive airway pressure) and bi-level airway pressure in treating adult patients.
The Spiritus™ Respiratory System is a single-patient interface accessory intended for use by patients who have been prescribed positive airway pressure treatment (PAP) including CPAP and BiPAP.
Device Description
The device is a single-patient-use, patient interface accessory for patients receiving positive airway pressure treatment including CPAP and BiPAP and comprises the nasal/tubing assembly and associated headgear.
The nasal cannula protuberances fit into the patient's nares effecting a substantially artight seal, facilitating the delivery of the positive airway pressure. Tubing is fitted to the nasal cannula via elbow connectors which may be used to secure the detachable headgear. The tubing fits to a "Y" connector to effect connection to the flow generator output tube.
The nasal cannula, tubing and connectors may be cleaned with mild soap and water for use by the same patient.
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K Number
K020337Device Name
READI-STRAND; MODEL PSSTRAND
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
2002-07-29
(178 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Worldwide Medical Technologies Readi-Strand intended use is to provide a carrier for radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach in and around the prostate gland.
Device Description
Not Found
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K Number
K020867Device Name
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
2002-05-20
(63 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Worldwide Medical Technologies Bone Marrow Aspiration/Core Needle is to obtain samples of aspirates and bone marrow for cytologic and histologic examination in the diagnosis and treatment of various diseases. The samples are typically taken by percutanious puncture of the posterior iliac crest of the pelvic bone.
Device Description
Worldwide Medical Technologies AspirCore
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K Number
K991344Device Name
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
1999-11-05
(200 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate.
Device Description
Not Found
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K Number
K981889Device Name
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
1998-07-31
(63 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.
Device Description
Worldwide Medical Technologies Introducer Needle for Biopsy Needles
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K Number
K982097Device Name
WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
1998-06-25
(10 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the Worldwide Medical Technologies Intracervical Block Needle is to inject anesthetic in the cervical area.
Device Description
Worldwide Medical Technologies Intracervical Block Needle
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