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510(k) Data Aggregation
K Number
K123822Device Name
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
Manufacturer
HK SURGICAL, INC.
Date Cleared
2013-09-27
(289 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
HK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KleinTouch Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch pump is not intended to be used as an IV infusion pump.
Device Description
Device Functionality: The KleinTouch Pump is an electrically or battery operated, manually controlled, peristaltic pump using three rollers to create pumping action in a section of sterile tubing.
Scientific Concept(s): The KTP is designed to specifically function with sterile single use only Klein Touch Tubing (KT20). Tubing must be primed before use. Please refer to the KT20 Instructions for Use for further details.
Physical And Performance Characteristics: Device Design Display: Color Graphic LCD Dual Foot Switches With Hose - Air Activated Dimensions: 11" x 10 ¾" x 5" Weight: 8.4 lbs.
Components Used: Motor Fluid Pathway Materials Silicone Inlet Hospital Power Cord Hospital Grade Plugs Barcode Reader Base, Plastic Battery Instrument Foam PCBA - Power Board PCBA, Main Circuit Board Pump, Peristaltic, 3-Roller, Fixed Clamp Switch, Rocker, Lighted
Physical Properties: The Pump is intended for use in combination with the KT20 tubing. The peristaltic pump using three rollers will create pumping action in KTP20 tubing set specifically designed for the KleinTouch Pump
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K Number
K032802Device Name
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
Manufacturer
HK SURGICAL, INC.
Date Cleared
2003-11-19
(71 days)
Product Code
QPB, MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
HK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HK Liposuction Aspiration Pump is for aesthetic body contouring.
Device Description
The HK Liposuction Pump is a powered suction pump/ aspirator which uses an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose(Suction Lipoplasty), soft tissue, and general surgical waste.
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K Number
K031432Device Name
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
Manufacturer
HK SURGICAL, INC.
Date Cleared
2003-08-07
(93 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
HK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.
Device Description
Not Found
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