Kaneka Corporation Osaka Plant

FDA Device Registration & Listing · Settsu-shi Osaka, JP · Registration 9614654

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
9614654
FEI Number
3002808904
Entity Name
Kaneka Corporation Osaka Plant
City/State/Country
Settsu-shi Osaka, JP
Establishment Address
5-1-1, Torikai-nishi,, Settsu-shi Osaka 5660072, JP
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
KANEKA CORP. (Owner Number: 9005249)
Owner / Operator Contact Address
2-3-18, Nakanoshima, Kita-ku, Osaka, JP-27 530-8288, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K210638
PMA Number
N/A

All Registered Proprietary Names

RX NC Takeru Liposorber LA-15 system Lixelle ?2-microglobulin Apheresis Column Metacross RX Plasmaflo OP-05W(A) Metacross OTW Crosstella OTW RX Takeru Liposorber LA-15 System Liposorber LA-15 System Crosstella RX R2P Crosstella RX R2P Metacross RX Crosperio OTW EDG v4 i-ED COIL

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 2017-07-09
MMY Lipoprotein, Low Density, Removal Unknown Class 3 N/A 2007-10-16
PDI Beta 2-Microglobulin Apheresis Column Unknown Class f N/A 2015-03-31
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-08-06
MDP Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma Unknown Class 3 N/A 2023-09-06
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2015-09-24
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2016-05-01
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2017-04-09
PBN Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients Unknown Class f N/A 2013-11-01
PBN Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients Unknown Class f N/A 2018-03-23
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2016-01-25
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2017-01-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2016-05-01
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-03-28
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2021-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Audra bogucki Business: Kaneka Medical America LLC Email: Audra.bogucki@kaneka.com Phone: (917) 6289870

Related Public Records

Same Entity

KANEKA CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3031408734 KANEKA CORPORATION TOMATOH PLANT Tomakomai-city Hokkaido, JP
3009761573 KANEKA MEDIX CORPORATION KANAGAWA PLANT Ashigara-Kami-gun Kanagawa, JP
3031550970 KANEKA MEDICAL VIETNAM Co.,Ltd. Ho Chi Minh, VN

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 9614654. Last updated year: 2026. Please use registration number 9614654 when referencing this establishment in official correspondence.
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