OrbusNeich Medical (Shenzhen) Co., Ltd.

FDA Device Registration & Listing · SHENZHEN Guangdong, CN · Registration 3003775186

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003775186
FEI Number
3003775186
Entity Name
OrbusNeich Medical (Shenzhen) Co., Ltd.
City/State/Country
SHENZHEN Guangdong, CN
Establishment Address
No.1st Jinkui Road, FUTIAN FREE TRADE ZONE, Shenzhen, China;, Floor 1 and Floor 3, Tower D, Tong'an industrial park, No.124, Yonghe Rd., Baoan, Shenzhen, China, SHENZHEN Guangdong 518038, CN
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
ORBUSNEICH MEDICAL CO. LTD (HONG KONG) (Owner Number: 9050384)
Owner / Operator Contact Address
Units 303 &305, 3/F, Building 20E Hong Kong Science Park Shatin, N.T., Hong Kong, No. 27-31 Au Pui Wan Street Fo Tan, N.T. HONG KONG SAR, Hong Kong, HK-NOTA --, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K180921
PMA Number
N/A

All Registered Proprietary Names

Sapphire NC ULTRA Coronary Dilatation Catheter Teleport Glide Microcatheter Jade PTA Scoreflex PTA scoring Balloon Catheter COREPASS Modular Microcatheter Scoreflex NC Scoring PTCA Catheter Sapphire II Pro Coronary Dilatation Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2024-09-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-06-04
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2018-03-02
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2021-02-04
PNO Catheter, Percutaneous, Cutting/Scoring Cardiovascular Class 2 870.1250 2021-02-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-03-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2020-04-12
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2020-04-12
NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown Class 3 N/A 2022-01-04
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-05-14
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-05-14

Official Correspondent

Denise Lau

US Agent Details

Amanda Kellar Business: OrbusNeich Medical, Inc. Email: akellar@orbusneich.com Phone: (954) 6477910

Related Public Records

Same Entity

ORBUSNEICH MEDICAL CO. LTD (HONG KONG)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19
K082339 Endocross, Ltd. ENABLER-P SUPPORT CATHETER 2008-11-20
K210009 CenterPoint Systems, LLC Guiding Catheter 2021-11-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04 N/A 2
Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003775186. Last updated year: 2026. Please use registration number 3003775186 when referencing this establishment in official correspondence.
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