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510(k) Data Aggregation
K Number
K221223Device Name
extriCARE® 3000 Negative Wound Pressure Therapy System
Manufacturer
Date Cleared
2023-02-09
(287 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Alleva Medical Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The extriCARE® 3000 Negative Pressure Wound Therapy System is intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. It is indicated for the following wound types:
- chronic
- · acute
- · traumatic
- subacute and dehisced wounds
- · partial-thickness burns
- · ulcers (such as diabetic or pressure)
- · flaps and grafts.
The extriCARE® 3000 Negative Pressure Wound Therapy System is intended for use in healthcare facilities.
Device Description
The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) pump is a portable, rechargeable, battery-powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed. The extriCARE 3000 Negative Pressure Wound Therapy (NPWT) is packaged and provided with the following components:
- 1. extriCARE 3000 Negative Pressure Wound Therapy Pump
- 2. extriCARE 3000 100cc Collection Canister
The extriCARE® 3000 Negative Pressure Wound Therapy (NPWT) pump accessories that are included in this 510(k) application and will be commercialized separately are the following:
- 1. extriCARE® 3000 100cc Collection Canister (additional canister replacements)
- 2. extriCARE® 3000 400cc Collection Canister
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