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510(k) Data Aggregation
K Number
K140099Device Name
LIGHTHOUSE URINARY CATHETER
Manufacturer
Date Cleared
2014-03-04
(47 days)
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
SEEDINGS LIFE SCIENCE VENTURES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate biopsy and brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUS-guided prostate biopsy and brachytherapy procedures by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.
Device Description
The Lighthouse™ Urinary Catheter is a 3-lumen Foley catheter. In addition to a System lumen for inflating the Foley balloon and a urine drainage lumen, the Lighthouse has a third lumen for filling 0.1cc - 1cc of air in a 4-cm length bladder along the shaft of the catheter. The Urethral Identification Bladder (UIB) has a maximum outer diameter of 24F (i.e. smaller than other urinary catheters that meet ASTM F623-99) when filled with a maximum 1cc volume described in the instructions for use (IFU) and provides echogenicity when viewed by a Transrectal Ultrasound (TRUS). The non-inflated UIB contains a narrow air space between the catheter shaft and the urethra, which provides an echogenic marker under TRUS and when necessary can be increased by adding 0.1cc - 1.0cc of volume via syringe.
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K Number
K131655Device Name
LIGHTHOUSE(TM) URINARY CATHETER
Manufacturer
Date Cleared
2013-11-04
(151 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
SEEDINGS LIFE SCIENCE VENTURES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lighthouse™ Urinary Catheter is intended for bladder/urinary tract drainage during prostate brachytherapy procedures where transrectal ultrasound (TRUS) imaging is used to visualize the prostate. The catheter additionally enhances identification of the course of the posterior aspect of the prostatic urethra during TRUSguided brachytherapy by creating an acoustic interface (i.e., air) between the catheter and the urethral wall via its urethral identification bladder.
Device Description
The Lighthouse™ Urinary Catheter is a 3-lumen Foley catheter. In addition to a lumen for inflating the Foley balloon and a urine drainage lumen, the Lighthouse has a third lumen for filling 0.1cc - 1cc of air in a 4-cm length bladder along the shaft of the catheter. The Urethral Identification Bladder (UIB) has a maximum outer diameter of 24F (i.e. smaller than other urinary catheters that meet ASTM F623-99) when filled with a maximum 1cc volume described in the instructions for use (IFU) and provides echogenicity when viewed by a Transrectal Ultrasound (TRUS). The non-inflated UIB contains a narrow air space between the catheter shaft and the urethra, which provides an echogenic marker under TRUS and when necessary can be increased by adding 0.1cc - 1.0cc of volume via syringe.
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Ask a specific question about this device
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