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510(k) Data Aggregation
K Number
K161445Device Name
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
Manufacturer
Date Cleared
2016-08-16
(83 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ADAPTA MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PerfIC Cath™ is intended for use in adult male patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
Device Description
The PerfIC Cath™ is a single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in length, with two (2) oval eyelet holes for intra-bladder urine drainage at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. The product will be available in a straight and Coude tip configuration (also termed a Tiemann tip). Additionally, the PerfiC Cath™ will be offered with either aqueous gel lubricant or hydrophilic coating. The distal end of the catheter is connected to a PVC urine collection bag. The product is available in a 14French only.
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K Number
K103043Device Name
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH
Manufacturer
Date Cleared
2011-01-07
(85 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ADAPTA MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PerfIC Cath™ is intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
Device Description
The PerfiC Cath™ is a straight single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in fength, with two (2) oval eyelet holes for intra-bladder urine collection at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. Liquid enters the catheter only via the lateral eyelets. The distal end of the catheter is connected to a PVC urine collection bag (volume = 900 ml). Thus, the PerfiC Cath™ device facilitates its essential function by providing a channel for the drainage of urine from the bladder into a collection bag, via a straight piece of PVC tubing. Adapta Medical, Inc. supplies the PerfIC Cath™ in one size, 14 Fr.
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