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510(k) Data Aggregation
K Number
K132815Device Name
PUREGRAFT 50 SYSTEM
Manufacturer
CYTORI THERAPEUTICS, INC.
Date Cleared
2014-01-24
(137 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
CYTORI THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cytori Puregraft 50 System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.
Device Description
The Puregraft 50 System is a sterile, single use, closed system intended for the preparation and delivery of autologous fat grafts back to the same patient for aesthetic body contouring in cosmetic and reconstructive surgery applications. The dual filtration bag system connects to an off the shelf sterile luer lock syringe through a swabable luer activated valves interface. The attached slider is used to facilitate the movement of liquids through the filter mesh and out of the Puregraft bag through the drain stub as waste. The Puregraft 50 System is composed of the following components: Outer Membrane (2), Filter 74 micron (1), Filter 800 micron (1), Tissue Port (1), Drain Port (1), Attached Slider (1). The Puregraft 50mL System is a sterile, single-use, 100mL capacity mixing bag measuring approximately 184 mm x 96 mm and consists of 2 filters layered between a polyvinyl chloride (PVC) outer shell and 2 ports on the bottom of the bag. Each port is labeled and designed to assure the proper connection is made with a luer fitting. The "tissue" port and the "drain" port contains a female swabable luer fitting designed to connect to a luer syringe. The "tissue" port and the "drain" port are designed as one-way valves to assure that the contents within the Puregraft 50mL Bag are not accidently spilled from the bag. The Puregraft 50mL Bag contains two (2) filters that are continuous within the bag. The first filter is a 800 micron filter mesh and the second filter is a 74 micron filter. The Puregraft 50 Bag has an attached plastic "slider" that is used to compress the Puregraft bag as a means to facilitate the movement of liquids through the filter mesh and out of the Puregraft bag to waste; through the "drain" port. All materials are medical grade and DEHP free.
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K Number
K113255Device Name
PUREGRAFT 850/PURE SYSTEM
Manufacturer
CYTORI THERAPEUTICS, INC.
Date Cleared
2012-03-07
(125 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
CYTORI THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Puregraft® 850/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.
Device Description
The Puregraft® 850/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. The Puregraft 850/PURE System consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly. The Puregraft® 850/PURE System is composed of the following components: Puregraft® 850 Bag, Puregraft® 850 Drain Bag, Tissue Access Port Adapter (TAPA), and Luer Lock Syringe Adapter. In addition to the Puregraft® Assemblies described above, the Puregran® 850/PURE System is used in combination with the following Class I hand-held manual instruments provided by Cytori Therapeutics: Easel and Slider.
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K Number
K092923Device Name
CYTORI PUREGRAFT 250/PURE SYSTEM
Manufacturer
CYTORI THERAPEUTICS, INC.
Date Cleared
2010-01-06
(105 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
CYTORI THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cytori PureGraft 250/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.
Device Description
The Cytori PureGraft 250/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. Cytori PureGraft 250/PURE consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly.
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K Number
K072587Device Name
CYTORI AFT SYSTEM
Manufacturer
CYTORI THERAPEUTICS, INC.
Date Cleared
2007-12-10
(87 days)
Product Code
MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
CYTORI THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cytori AFT System is used in the aspiration, harvesting, filtering and transfering of autologous tissue.
The Cytori AFT System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery
- · Thoracic Surgery
- · Laparoscopic Surgery
The Cytori AFT System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
Device Description
The Cytori AFT System is provided in two packaged assemblies: 1). Cytori AFT Tissue Collection Canister and 2). Cytori AFT Delivery Syringe. The Cytori AFT Tissue Collection Canister is a single-use disposable device designed to utilize house vacuum to create suction within the hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the adipose tissue into the collection canister. The Cytori AFT Delivery Syringe is a, sterile, single-use 60cc piston syringe.
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K Number
K063235Device Name
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
Manufacturer
CYTORI THERAPEUTICS, INC.
Date Cleared
2007-01-24
(91 days)
Product Code
QPB, MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
CYTORI THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cytori Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:
- · Neurosurgery
- · Gastrointestinal and Affiliated Organ Surgery
- · Urological Surgery
- · Plastic and Reconstructive Surgery
- · General Surgery
- · Orthopedic Surgery
- · Gynecological Surgery
- · Thoracic Surgery
- · Laparoscopic Surgery
The Cytori Lipoplasty System is indicated for use when the fragmentation, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
The Celase Reagent is intended for use in the fragmentation, disaggregation, and liquefaction of soft tissues and subcutaneous fatty tissues within the Lipoplasty System's Collection Canister.
Device Description
The Cytori Lipoplasty System with Celase Reagent is provided in two packaged assemblies: 1). Lipoplasty Unit and 2). Celase Reagent. The Lipoplasty Unit is a single-use disposable device designed to utilize house vacuum to create suction within the hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the adipose tissue into the collection canister. The Celase Reagent is a single-use, non-reusable reagent designed to digest the waste tissue in the collection canister as a means to allow the non-reasons rought designed the screen and mitigate down-stream clogging and blockage in the waste system.
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K Number
K060482Device Name
CYTORI CELUTION CELL CONCENTRATION DEVICE
Manufacturer
CYTORI THERAPEUTICS, INC.
Date Cleared
2006-09-28
(217 days)
Product Code
CAC
Regulation Number
868.5830Why did this record match?
Applicant Name (Manufacturer) :
CYTORI THERAPEUTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cytori Celution™ Cell Concentration Device is indicated for the collection, concentration, washing, and reinfusion of autologous cells collected intraoperatively or postoperatively to obtain concentrated blood cells for reinfusion. Such areas of application may include, but are not limited to, the following:
- · General Surgery
- · Cardiovascular Surgery
- · Orthopedic Surgery
- · Vascular Surgery
- · Plastic/Reconstructive Procedures
- Obstetric/Gynecologic Surgery
- · Neurosurgical Procedures
- · Thoracic Surgery
- · Transplantation Surgery
- · Emergency / Trauma Procedures
- Urology Procedures
- · Postoperative Treatment Areas
Device Description
The Cytori Therapeutics Celution™ Cell Concentration Device consisting of a centrifuge, blood collection canister, peristaltic pumps, pinch valves, sensors, controller and associated vacuum fluorescent display. The Celution Cell Concentration Device weighs approximately 170 lbs, measures 35 inches with a height of 55 inches, and is equipped with lockable caster wheels for portability in the operating room. The Celution Cell Concentration Device is used in conjunction with a sterile disposable set that consists of a blood collection canister, a concentration chamber, a waste bag, and associated tubing. The Disposable Set for the Celution Cell Concentration Device is provided in a separate sterile package and mounted onto the device by the user at the time of use by contacting the tubing with the peristaltic pumps and pinch valves. Various washing solutions are provided by the user and connected to the single-use disposable set through the use of Spike ports attached to the tubing. The user is able to choose between large and small volume disposable sets based on the user's needs. The large volume set (190ml chamber size) is referred to as the "Macro" disposable set while the small volume set (70ml chamber size) is referred to as the "Micro" disposable set. The Macro and Micro disposable sets consists of the same essential configuration of tubing, bags, rotating seal, etc., and operate on the same essential principles of peristaltic pumping to transmit fluids, centrifugation, etc. The Macro and Micro disposable sets differ with respect to their collection chambers and continuous processing capabilities as the 190 ml chamber can only process one time and must have product removed from the chamber with a syringe and needle. The 70 ml chamber can process multiple runs and pump the cellular product to a pull/donif interface. The centrifuge of the Celution Cell Concentration Device concentrates and pellets the cells in the concentration chamber and the peristaltic pumps and associated pinch valves interact with the disposable tubing to remove the superitiation from the pelleted cells and deliver the waste to the waste bag. The Celution Cell Concentration Device then washes the cells by delivering the user-provided washing solutions to the cells through the use of the same peristaltic pumps and pinch valves. After the wash cycles, the pelleted cells are them available for use by the physician. The Celution Cell Concentration Device is operated by the user through use of a menu driven user interface. The device operates on a user interaction principle through use of the key pad by requiring the user to confirm the completion of prompted tasks. The device also comprehends timing on to the next programmed step. The device also comprehends programmed steps as there are sensors built into the device to confirm the execution of critical tasks and/or equipment error conditions.
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