ORBUSNEICH MEDICAL CO. LTD (HONG KONG)

FDA Device Registration & Listing · Fo Tan, N.T., HK · Registration 3015002281

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
3015002281
FEI Number
3015002281
Entity Name
ORBUSNEICH MEDICAL CO. LTD (HONG KONG)
City/State/Country
Fo Tan, N.T., HK
Establishment Address
Units 303 &305, 3/F, Building 20E, Hong Kong Science Park, Shatin, N.t., Hong Kong, No. 27-31 Au Pui Wan Streeet, Fo Tan, N.T. NA, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
OrbusNeich Medical Co. Ltd (Hong Kong) (Owner Number: 10059958)
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 852, 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 Scoreflex NC Scoring PTCA Catheter Teleport Microcatheter Scoreflex PTA Scoring Balloon Catheter Sapphire II PRO Balloon Dilatation Catheter Jade PTA Balloon Dilatation Catheter Jade PTA Balloon Dilatation Catheter Sapphire NC 24 Coronary Dilatation Catheter Teleport Glide Microcatheter Teleport XT Microcatheter JADE PLUS PTA Balloon Dilatation 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 2025-01-17
NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown Class 3 N/A 2022-01-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-03-14
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
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2021-02-04
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2021-02-04
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2021-02-04
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-03-14
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2021-12-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-06-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-01-18
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-06-28
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2019-03-14
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2019-03-14

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 3015002281. Last updated year: 2026. Please use registration number 3015002281 when referencing this establishment in official correspondence.
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