Asahi Kasei Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Asahi Kasei Medical Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009960884
• FEI Number: 3009960884
• Name: Mauricio Pineda
• Owner & Operator: Asahi Kasei Medical Co., Ltd.
• Contact Address: 1-1-2 Yurakucho ; Chiyoda-ku JP-13 Tokyo 100-0006 JP
• US Agent:
  • Mauricio Pineda
  • Asahi Kasei Medical America Inc.
  • 847 6415904
  • mauricio.pineda@akmamerica.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1855 Elmdale Avenue ; Glenview, IL 60026 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3007340888
• FEI Number: 3007340888
• Name: Asahi Kasei Medical MT Corp. Okatomi Plant
• Owner & Operator: Asahi Kasei Medical Co., Ltd.
• Contact Address: 1-1-2 Yurakucho ; Chiyoda-ku JP-13 Tokyo 100-0006 JP
• US Agent:
  • Mauricio Pineda
  • ASAHI KASEI MEDICAL AMERICA INC.
  • 847 6415904
  • mauricio.pineda@akmamerica.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5-4960 NAKAGAWARA-MACHI ; NOBEOKA-SHI Miyazaki, 882-0031 JP
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 8010002
• FEI Number: 3002806407
• Name: Mauricio Pineda
• Owner & Operator: Asahi Kasei Medical Co., Ltd.
• Contact Address: 1-1-2 Yurakucho ; Chiyoda-ku JP-13 Tokyo 100-0006 JP
• US Agent:
  • Mauricio Pineda
  • ASAHI KASEI MEDICAL AMERICA INC.
  • 847 6415904
  • mauricio.pineda@akmamerica.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1855 Elmdale Avenue ; Glenview, IL 60026 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
PMA P820033S015 Asahi Kasei Medical Co., Ltd.	Plasmaflo OP-05W (A)	2022-02-08
PMA P820033S014 Asahi Kasei Medical Co., Ltd.	Plasmaflo OP-05W(A)	2021-03-03
PMA P820033S013 Asahi Kasei Medical Co., Ltd.	Plasmaflo OP-05W(A)	2020-10-22
PMN H170002 | PBN Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]	Liposorber LA-15 system	2018-06-21
PMA P820033S012 Asahi Kasei Medical Co., Ltd.	Plasmaflo OP-05W(A)	2018-02-15
PMA P820033S011 Asahi Kasei Medical Co., Ltd.	Plasmaflo	2018-01-17
PMN K162248 ASAHI KASEI MEDICAL CO., LTD.	Asahi ViE-U Series Dialyzer	2017-05-03
PMN K153344 | KDI Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]	REXEED-S SERIES DIALYZERS	2016-05-12
PMN K153344 | KDI Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]	REXEED-S SERIES DIALYZERS	2016-05-12
PMN K153344 | KDI Asahi Kasei Medical MT Corp. Okatomi Plant [Asahi Kasei Medical Co., Ltd.]	REXEED-S SERIES DIALYZERS	2016-05-12
PMA P820033S010 Asahi Kasei Medical Co., Ltd.	PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR	2016-03-09
PMN K153344 Asahi Kasei Medical Co., Ltd.	Asahi REXEED-S Series Dialyzer	2015-12-17
PMA P820033S009 Asahi Kasei Medical Co., Ltd.	PLASMAFLO	2015-12-03
PMN H120005 | PBN Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]	Liposorber LA-15 system	2013-11-19
PMN K121409 ASAHI KASEI MEDICAL CO., LTD.	ASAHI REXEED-SX/LX SERIES DIALYZER	2013-02-06
PMN P910018 | MMY Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]	Liposorber LA-15 system	2013-01-30
PMN P820033 | MDP Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]	Plasmaflo OP-05W(A)	2012-04-10
PMN P820033 | MDP Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]	Plasmaflo OP-05W(A)	2012-04-10
PMA P820033S008 Asahi Kasei Medical Co., Ltd.	PLASMAFLO OP-05W (A)	2011-11-02
PMA P820033S007 Asahi Kasei Medical Co., Ltd.	PLASMAFLO OP-05W (A)	2011-01-28
PMA P820033S006 Asahi Kasei Medical Co., Ltd.	PLASMAFLO OP-05W(A)	2010-08-06
PMA P820033S005 Asahi Kasei Medical Co., Ltd.	PLASMAFLO OP-05W (A)	2010-03-16
PMN K082515 ASAHI KASEI MEDICAL CO., LTD.	ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX	2008-10-03
PMN K051187 ASAHI KASEI MEDICAL CO., LTD.	REXEED SERIES DIALYZERS	2005-06-08
PMA P820033S001 Asahi Kasei Medical Co., Ltd.	PLASMAFLO AP-05H ASAHI PLASMA SEPARATOR	1986-01-08
PMA P820033 Asahi Kasei Medical Co., Ltd.	PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR	1983-07-05

Similar & Related FDA Registered Companies

• Asahi Kasei Medical Co., Ltd.1-105 Kanda Jinbochochiyoda-kutokyo 101-8-8101 PMA NumberP820033 Supplement NumberS016 Date Received12/09/2022 Decision Date01/05/2023 Product Code MDP  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	S4752	ASAHI KASEI MEDICAL CO. LTD
CAGE Code	S4752	ASAHI KASEI MEDICAL CO. LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092457211	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	369 CTN
2020092172088	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	369 CTN
2020091976538	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	369 CTN
2020082855847	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	366 CTN
2020082759453	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	366 CTN
2020082471796	Puerto Manzanillo,Panama -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	366 CTN
2020081071308	Manzanillo,Mexico -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	610 CTN
2020072778667	Manzanillo,Mexico -> San Juan, Puerto Rico	LEUCOCYTE REDUCTION FILTERS	476 CTN