FDA.reportPublic FDA data

510(k) K233505

Device
Sapphire ULTRA Coronary Dilatation Catheter
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
510(k) number
K233505
Product code
LOX
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-15
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
K233499Sapphire NC ULTRA Coronary Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.2024-08-16
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