Search Results
Found 28 results
510(k) Data Aggregation
K Number
K162790Device Name
V.A.C.ULTA Negative Pressure Wound Therapy System
Manufacturer
KCI USA, Inc. (Kinetic Concepts, Inc.)
Date Cleared
2017-01-26
(114 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(Kinetic Concepts, Inc.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V.A.C.ULTA™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
Instillation Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C.ULTA™ Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Negative Pressure Wound Therapy in the absence of instillation may also be used for:
The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.
The management of the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Device Description
The V.A.C.ULTA™ Negative Pressure Wound Therapy System is a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions.
The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negative pressure therapy for the removal of wound exudate and when applicable instilled solutions. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillation solutions and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure during negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for help and alarm functions.
Ask a Question
K Number
K161897Device Name
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2016-10-04
(85 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PREVENA DUO Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate va the application of negative pressure wound therapy.
The PREVENA PLUS DUO Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Device Description
Both the PREVENA DUO™ Incision Management System (with the PREVENA 125 Therapy Unit) and the PREVENA PLUS DUO™ Incision Management System (with the PREVENA PLUS 125 Therapy Unit) are negative pressure wound therapy systems designed for the management of two surgical incisions simultaneously with one PREVENA Therapy Unit. Both systems provide two PREVENA PEEL & PLACE Dressings (which can be for linear incisions up to 13 or 20 cm in length) which are connected to their respective therapy units via a new PREVENA Y-Connector. Therapy is continuously applied to each incision at -125 mmHg for 2 to 7 days. Length of therapy is per surgeon preference.
Ask a Question
K Number
K160451Device Name
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2016-06-20
(123 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C. Uta Negative Pressure Wound Therapy System with and without is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Device Description
The V.A.C. VeraFlo Cleanse Choice Dressing System is intended for use with the V.A.C. Ulta Negative Pressure Wound Therapy System to deliver negative pressure wound therapy (NPWT) as well as facilitate the instillation of fluid to the wound.
The V.A.C. VeraFlo Cleanse Choice Dressing System has the same basic components as the predicate V.A.C. VeraFlo Cleanse Dressing cleared under K103156. The only difference between the two systems is the configuration of the dressing.
The subject system has a dressing that is designed with 3 separate layers. The predicate dressing, on the other hand, is a single spiral shaped rod configuration. The materials of the dressing are the same.
Ask a Question
K Number
K141017Device Name
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2015-08-20
(486 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudate yia the application of negative pressure wound therapy.
Device Description
The Prevena Incision Management System provides surgical incision management via the application of negative pressure wound therapy over an incision site that has been surgically closed with sutures or staples. The Prevena System is applied to the incision site immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The Prevena Incision Management System consists of: A Prevena Dressing (Prevena Peel & Place Dressing or Prevena Customizable Dressing and A source of negative pressure wound therapy, which may be one of the following KCI therapy units with its associated canisters: Prevena 125 Therapy Unit ActiV.A.C. Therapy Unit V.A.C. Freedom Therapy Unit InfoV.A.C. Therapy Unit
Ask a Question
K Number
K133232Device Name
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2014-03-24
(154 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Device Description
Negative pressure wound therapy system for application to surgically closed incisions.
Ask a Question
K Number
K123878Device Name
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2013-01-15
(29 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Device Description
Negative pressure wound therapy system for application to surgically closed incisions.
Ask a Question
K Number
K121883Device Name
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2012-10-11
(105 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Device Description
Negative pressure wound therapy system for application to surgically closed incisions.
Ask a Question
K Number
K120499Device Name
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2012-10-05
(227 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ABThera Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. The Intended Use of this system is in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.
Device Description
The therapy system consists of a therapy unit which delivers negative pressure through a tubing set to the dressing which is placed into the open abdomen. Controls within the therapy unit monitor delivery of negative pressure and provide safety alarms. The dressing manifolds negative pressure from the therapy unit and protects abdominal contents. A canister collects wound fluids removed under negative pressure.
Ask a Question
K Number
K103156Device Name
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2011-03-14
(139 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V.A.C.Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Negative Pressure Wound Therapy in the absence of instillation is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
The instillation option is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.
The V.A.C.Ulta Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.
Device Description
A dressing component of a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions
Ask a Question
K Number
K102956Device Name
V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING
Manufacturer
KCI USA, INC. (KINETIC CONCEPTS, INC.)
Date Cleared
2010-12-15
(72 days)
Product Code
OMP
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
(KINETIC CONCEPTS, INC.)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
Device Description
The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C. Therapy System which is an integrated negative pressure wound management system. The dressing is polyurethane foam with a silver coating designed specifically for use with the V.A.C. family of negative pressure wound therapy devices.
Ask a Question
Page 1 of 3