FDA.reportPublic FDA data

510(k) K233499

Device
Sapphire NC ULTRA Coronary Dilatation Catheter
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) number
K233499
Product code
LOX
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-16
Date received
2023-10-31
Regulation
870.5100
Classification name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jerry Cheung
Address
#1 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 LOX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252116Firefighter™ Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.2026-04-07
K254022FLASH Flex™ Aorto-Ostial Angioplasty SystemVerge Medical, Inc.2026-04-02
K252295RyureiTerumo Corporation2026-03-27
K251970Sprinter Legend Rapid Exchange Balloon Dilatation CatheterMedtronic, Ireland2026-01-17
K242969Pantera Pro; Pantera LEOBiotronik, Inc.2024-10-25
K233505Sapphire ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.2024-08-15
K233729Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58Vascular Solutions, LLC2024-05-31
K223189Firefighter™ NC Pro PTCA Balloon CatheterShanghai MicroPort Medical (Group) Co., Ltd.2023-07-21
K230374Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)Dongguan TT Medical, Inc.2023-06-29
K230705POT PTCA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.2023-04-11
K223022SC HONKYTONK PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.2023-02-15
K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.2022-12-21
K220634NC TREK NEO Coronary Dilatation CatheterAbbott Vascular2022-06-30
K220629Emerge Monorail PTCA Dilatation CatheterBoston Scientific2022-03-24
K212393OPN NC PTCA Dilatation CatheterSis Medical AG2022-03-14