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510(k) Data Aggregation
K Number
K232379Device Name
PREVENT Kit
Manufacturer
Clear Choice Therapeutics
Date Cleared
2024-02-05
(181 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Clear Choice Therapeutics
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PREVENT™ Kit is intended to be used as an alternative to foam and other negative pressure wound therapy dressings when used in conjunction with the CCT1 and CCT Mini Negative Pressure Wound Drainage Pumps (K082311) for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT1 or CCT Mini Negative Pressure Wound Drainage Pumps, the PREVENT™ Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudate, infectious material and tissue debris.
The PREVENT™ Kit is appropriate for use on the following wounds:
- Pressure Ulcers
- Diabetic/Neuropathic Ulcers
- Venous Insufficiency Ulcers
- Traumatic Wounds
- Post-Operative and Dehisced Surgical Wounds
- Skin Flaps and Grafts
The system is for prescription use only.
Device Description
The PREVENT™ Kits are composed of sterile, single-use, disposable components that are designed to be used with a pump to deliver NPWT to a wound surface as part of a negative pressure wound therapy (NPWT) system.
The dressing kit includes 1) a thermoplastic elastomer (TPE) dressing (Prevent™ barrier) used to contact the wound bed and allow the application of NPWT to the wound and to provide flow pathways for the removal of exudate, 2) occlusive drape(s) to create a seal around the wound, and 3) a dome assembly with drainage tubing that is connected to the suction tubing of the disposable canister of the negative pressure pump to create a closed system.
The negative pressure pump creates a vacuum that provides the suction needed to remove wound exudate from the wound surface to the collection canister.
The wound contact layer is provided in a single size and thickness, so the kits are provided in a single size.
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K Number
K211277Device Name
Theia NPWT Foam Wound Dressing Kit
Manufacturer
Clear Choice Therapeutics, Inc.
Date Cleared
2021-12-16
(233 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Clear Choice Therapeutics, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps for the application of negative pressure wound therapy to the wound. When used in conjunction with the CCT Mini or CCT1 Negative Pressure Wound Drainage Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds:
- Pressure Ulcers
- · Diabetic/Neuropathic Ulcers
- · Venous Insufficiency Ulcers
- · Traumatic Wounds
- · Post-Operative and Dehisced Surgical Wounds
- · Skin Flap and Grafts
Device Description
The Theia NPWT Foam Wound Dressing Kits are sterile, single use, disposable dressings for use with the CCT Mini or CCT1 Negative Pressure Wound Drainage pumps for the application of negative pressure wound therapy (NPWT) to the wound. The kits include a foam dressing made of black reticular polyether based polyurethane hydrophobic foam material, occlusive drape(s), and a dome assembly consisting of a single lumen dome, dome skirt, and drainage tubing with clamp and female luer lock connector. The foam dressing covers the wound and the transparent occlusive drape covers the foam dressing and creates a seal around the wound. The drainage tubing connects to the exudate canister of the negative pressure pump. The powered negative pressure pump delivers negative pressure to the dressing to suction wound exudate into the exudate canister of the pump. The dressing kits are available in three sizes (small, medium, large) based on foam dressing size (length x width) and in two foam dressing thicknesses (1.5 and 3.0 cm), for a total of six dressing kits.
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K Number
K073213Device Name
THERABOND ANTIMICROBIAL BARRIER SYSTEMS
Manufacturer
CHOICE THERAPEUTICS
Date Cleared
2008-05-28
(196 days)
Product Code
FRO, FDA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CHOICE THERAPEUTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TheraBond Antimicrobial Barrier Systems are indicated for use in light to moderately exuding partial and full thickness wounds including traumatic wounds, surgical wounds, donor sites, 1st and 2nd degree burns, as well as decubitus ulcers, diabetic ulcers and vascular ulcers. TheraBond may be used over debrided and partial thickness wounds.
Device Description
The TheraBond Antimicrobial Barrier Systems consist of a knitted, flexible, silver-plated nylon-based fabric. The device is available in several sizes and configurations including wound contact dressings, island dressings and wraps.
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