FDA.reportPublic FDA data

510(k) K201794

Device
Jade
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) number
K201794
Product code
LIT
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-28
Date received
2020-06-30
Regulation
870.1250
Classification name
Catheter, Angioplasty, Peripheral, Transluminal
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Daniel Zhang
Address
#1st Jinkui Rd. Futian Free Trade Zone Shenzhen CN 518038 518038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIT#

510(k), Device, Applicant table
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K241740Finesse Injectable™ PTA Balloon Dilatation CatheterSumma Therapeutics2024-07-16
K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.2024-07-11
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K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.2024-06-11
K231402HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.2023-12-20
K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC2023-05-26
K214009D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.2023-04-05
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