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510(k) Data Aggregation
K Number
K242254Device Name
D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
Manufacturer
DK Medical Technology Co., Ltd.
Date Cleared
2025-04-21
(264 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
DK Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D-KuttingTm LL Peripheral Scoring Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.
Device Description
The Peripheral Scoring Balloon Dilatation Catheter is an over the wire (OTW) catheter. It features a non-compliant balloon with 3 scoring elements mounted longitudinally on its outer surface. The scoring element is attached on the surface of balloon by adhesive. The scoring elements were tightly circled by a nitinol wire and the cross section of the scoring element is a triangular. The length of the scoring element is according to effective length of balloon. The catheter has two radiopaque marker bands, which fluoroscopically indicates the expanded part of the balloon and aid in the placement of the balloon and scoring element and to facilitate proper placement. The two radiopaque marker bands are located on the inner-lumen which is underneath the balloon. The catheter includes a tapered tip to facilitate advancement of the catheter to and through the inflation site. A lubricious coating is applied at from the distal tip to shaft tubing to enhance insertion and withdrawal performance. The inner lumen in the shaft tubing and ends in a Y-connector manifold hub with 2 Luer lock fittings. The straight manifold port is used to pass the catheter over the suitable guidewire. The second side port communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub. The balloon is folded an inserted in a PTFE casing to protect the balloon and scoring element. The Peripheral Scoring Balloon Dilatation Catheter is offered in balloon diameters ranging from 2.5mm-7.0mm and lengths are from 20mm to 150mm. The catheter length is 90cm, 135cm and 150cm and is compatible with 0.014″ or 0.018″ guide wires accordingly.
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K Number
K243118Device Name
Arm Blood Pressure Monitor (model: BPM-A7VL)
Manufacturer
Shenzhen IMDK Medical Technology Co., Ltd.
Date Cleared
2024-11-26
(57 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen IMDK Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.
Device Description
Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended for measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm~33cm and cuff of size 33cm~47cm.
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K Number
K232207Device Name
D·Kutting PTA Scoring Balloon Dilatation Catheter
Manufacturer
DK Medical Technology Co., Ltd.
Date Cleared
2024-03-07
(225 days)
Product Code
PNO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
DK Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Device Description
The D·Kutting™ PTA Scoring Balloon Dilatation Catheter is an Over-The-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.018" or 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with Luer lock fillings. 3 scoring wires between the two marker bands are radially distributed every 120° and mounted on the surface of the balloon. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D. Kutting™ PTA Scoring Balloon Dilatation Catheter will be available with balloon diameters 4.0 mm to 8.0 mm, balloon lengths 20 mm to 80 mm and with catheter lengths of 50 cm, 90 cm, and 130 cm. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub.
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K Number
K233040Device Name
EMS/TENS Massager Device
Manufacturer
Shenzhen IMDK Medical Technology Co., Ltd.
Date Cleared
2024-02-12
(140 days)
Product Code
NUH, NGX
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen IMDK Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Device Description
Not Found
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K Number
K214009Device Name
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
Manufacturer
DK Medical Technology Co., Ltd.
Date Cleared
2023-04-05
(516 days)
Product Code
LIT, DOY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
DK Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.
Device Description
The D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fillings. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 150 mm and with shaft lengths of 50 cm, 75 cm, and 130 cm.
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K Number
K221979Device Name
Pulse Oximeter (Model C101A2, C101B1, C101A3)
Manufacturer
Shenzhen IMDK Medical Technology CO., Ltd.
Date Cleared
2022-10-16
(103 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen IMDK Medical Technology CO., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fingertip Pulse Oximeter (Model:C101A2,C101B1,C101A3) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
Device Description
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. The pulse oximeter, model C101A2, C101B1, C101A3 is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.
The device is not for life-supporting or life-sustaining, not for implant.
The device is not provided sterile and is NOT a reprocessed single-use device.
The device is a spot-check pulse oximeter and does not include alarms.
The device does not support the measurement in the condition of low perfusion.
The device is not intended for life-supporting or life-sustaining.
The device is reusable and does not need sterilization.
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K Number
K173123Device Name
Pulse Oximeter
Manufacturer
Shenzhen IMDK Medical Technology Co., Ltd.
Date Cleared
2018-08-13
(318 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen IMDK Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fingertip Pulse Oximeter C101H1 is a non-invasive device intended for spot checking of function of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
Device Description
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained.
The pulse oximeter, C101H1, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring. The device is not for life-supporting or life-sustaining, not for implant.
The device is not provided sterile and is NOT a reprocessed single-use device.
The device is a spot-check pulse oximeter and does not include alarms.
The device does not support the measurement in the condition of low perfusion.
The device is not intended for life-supporting or life-sustaining.
The device is reusable and does not need sterilization.
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K Number
K180419Device Name
Ultrasonic Doppler (Model YM-2T8)
Manufacturer
Shenzhen IMDK Medical Technology Co., Ltd.
Date Cleared
2018-07-19
(154 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen IMDK Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultrasonic Doppler uses continuous-wave Doppler to detect fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Ultrasonic Doppler is intended for use by trained healthcare professionals only in a clinical setting.
Device Description
The Ultrasonic Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and organic light-emitting diode screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user.
The main unit is powered by two 1.5V AA alkaline batteries.
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