Arteriocyte Medical Systems Inc

FDA Filings

This page includes the latest FDA filings for Arteriocyte Medical Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006788678
FEI Number3006788678
NameArteriocyte Medical Systems, Inc.
Owner & OperatorArteriocyte Medical Systems, Inc.
Contact Address45 South Street
Hopkinton MA 01748 US
Official Correspondent
  • Neil Kizer
  • x-508-4978964-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address45 South Street
Hopkinton, MA 01748 US
Establishment Type
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Magellan Influx 2023-06-14
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise Sapphire 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise Diamond 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise Diamond 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Precise 2023-06-07
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Sterilization Tray 2022-12-06
ARTERIOCYTE MEDICAL SYSTEMS, INC.
InQu IQSP-MX-1252022-07-01
ARTERIOCYTE MEDICAL SYSTEMS, INC.
InQu IQSP-GR-1302022-07-01
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Platelet Separator TRU2002022-06-10
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Platelet Separator TRU1002022-06-10
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Platelet Separator MAG2002022-06-10
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Platelet Separator MAG1002022-06-10
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Platelet Separator BTI2002022-06-10
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Platelet Separator AMS1002022-06-10
Arteriocyte Medical Systems, Inc
Platelet And Plasma Separator For Bone Graft Handling2022-03-17
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical Tools for Erythrocyte and Marrow Preparation Kit MAR01-O-252020-12-22
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical Tools for Erythrocyte and Marrow Preparation Kit 2020-12-22
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Magellan Complete Disposable Kit 2020-07-23
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Aspiration Kit 2020-07-23
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit 2020-07-23
ARTERIOCYTE MEDICAL SYSTEMS, INC.
CP Disposable Kit with 45mm Lightning Needle 2020-07-23
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Kalitec MAR0Max Convenience Kit 2020-07-23
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Magellan Complete One Source Kit 2020-04-20
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Aspiration Kit 2019-12-18
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit 2019-12-17
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit 2019-12-17
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit 2019-12-17
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max Plus 2.5cc Convenience Kit MAR0MaxPlus2.52019-11-13
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max Plus 10cc Convenience Kit MAR0MaxPlus102019-11-13
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse 2019-11-13
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse 2019-11-13
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Fuse 2019-11-13
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Magellan® RO-Max Convenience Kit RO-Max2019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Magellan® Complete One Source Kit RO-3102019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Magellan® Complete Disposable kit RO-3002019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Serum Dispenser Kit MSD4052019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max-Duo Convenience Kit MAR0Max-Duo2019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR02-O2019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AUTOSPIN MAR01 Sterile disposable convenience kit MAR01-BTI-802019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AUTOSPIN MAR01 Sterile disposable convenience kit MAR01-BTI-452019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01-AO Convenience Kit MAR01-AO2019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR01-602019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete Pack COS3202019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete pack COS3102019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Basic platelet separator kit BTI3052019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete Pack BOS3602019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete pack BOS3502019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
BioBandage Convenience Kit BI0BAND2019-11-05
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Magellan Complete Disposable Kit 2019-06-21
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit TruMAR0-O-452019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TruMAR0 Convenience kit TruMAR02019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration kit TRU8002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete one source kit TRU3102019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete Disposable Kit TRU300-O2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete Disposable Kit TRU3002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Ratio Dispenser Kit MRD5052019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Basic Platelet Separator Kit MDK3052019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Autologous Platelet Separator Disposables Kit MDK3002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max Plus 5cc Convenience Kit MAR0MaxPlus52019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max QuickDraw Convenience Kit MAR0Max802019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max QuickDraw Convenience Kit MAR0Max452019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max Convenience kit MAR0Max2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration kit MAR0880-O2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration kit MAR08802019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration kit MAR08602019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration kit MAR0845-O2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration kit MAR08452019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration kit MAR08302019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Aspiration Kit MAR08002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Basic One Source Kit MAR05052019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0Max Complete disposable kit MAR03002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR02-O-802019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR02-O-452019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR01-OFC2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR01-O-802019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR01-O-452019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR01-O2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AUTOSPIN MAR01 Sterile disposable convenience kit MAR01-BTI-80-O2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AUTOSPIN MAR01 Sterile disposable convenience kit MAR01-BTI-45-O2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Surgical Tools for Erythrocyte & Marrow Preparation Kit MAR01-ATS2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR01 Convenience Kit MAR01-5002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit MAR012019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Platelet Separation Chamber M932793A00102019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
CP Disposable Kit 2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Disposable sterile kit BTI9802019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Disposable sterile kit BTI9452019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
AUTOSPIN Disposable sterile kit BTI9002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit AMSSV2019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Sterile cup kit AMS5002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Basic One Source Kit AMS3502019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAGELLAN Complete One Source Kit AMS3142019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete One Source Kit AMS3122019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete one source kit AMS3102019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Basic disposable kit AMS3052019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Complete disposable kit AMS3002019-04-09
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Surgical tools for erythrocyte & marrow preparation kit 40-K10-00012019-04-09
Arteriocyte Medical Systems, Inc., Terumo BCT, Inc., Terumo BCT, Ltd.
Prescription Medication2019-02-01
Arteriocyte Medical Systems, Inc.
INQU PASTE MIX2018-04-05
Arteriocyte Medical Systems, Inc.
INQU PASTE MIX PLUS2018-04-05
Arteriocyte Medical Systems, Inc.
ENDOSS2018-04-05
Arteriocyte Medical Systems, Inc.
InQu2018-04-05
Arteriocyte Medical Systems, Inc.
InQu2018-04-05
Arteriocyte Medical Systems, Inc.
LTN45 - MAGELLAN? Lightning Needle?2016-03-30
Arteriocyte Medical Systems, Inc.
LTN45 - MAGELLAN? Lightning Needle?2016-03-30
Arteriocyte Medical Systems, Inc.
MAR0 FS - 200 Micron Blood Component Filter and Syringe Adapter2013-12-12
ARTERIOCYTE MEDICAL SYSTEMS, INC.
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER2013-10-04
Arteriocyte Medical Systems, Inc.
Anticoagulant Citrate Dextrose A ACD-A2011-05-11
Arteriocyte Medical Systems, Inc.
VetPRP - MAGELLAN? Basic Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
Turbine Autologous Concentration Kit2007-11-26
Arteriocyte Medical Systems, Inc.
TRUMAR0 - MAGELLAN? TruMAR0? Convenience Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MDK300 - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAR0Max - MAGELLAN? MAR0Max Quickdraw Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAR0Max - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAR02-O - MAGELLAN? Surgical Tools for Erythrocyte and Marrow Preparation Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAR01-O - MAGELLAN? Surgical Tools for Erythrocyte and Marrow Preparation Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAR01-BTI-80-O MAGELLAN? Sterile Disposable Convenience Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAR01-BTI-45-O MAGELLAN? Sterile Disposable Convenience Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAR01 - MAGELLAN? Surgical Tools for Erythrocyte and Marrow Preparation Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAG200 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
BTI305 - AUTOSPIN? MAGELLAN? Basic Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
BTI300 - AUTOSPIN? MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
BTI200 - AUTOSPIN? MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
BIOBAND - MAGELLAN? BIOBANDAGE? KIT2007-11-26
Arteriocyte Medical Systems, Inc.
AMS300 - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
AMS100 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
TRU310 - MAGELLAN? Complete One Source Kit2007-11-26
Arteriocyte Medical Systems, Inc.
TRU300 - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
TRU200 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
TRU100 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
MDK300 - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
MAG200 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
AMS310 - MAGELLAN? Complete One Source Kit2007-11-26
Arteriocyte Medical Systems, Inc.
AMS305 - MAGELLAN? Basic Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
AMS300 - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
AMS100 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
AMS505 - MAGELLAN? Ratio Dispenser Kit2007-11-26
Arteriocyte Medical Systems, Inc.
AMS350 - MAGELLAN? BASIC ONE SOURCE KIT2007-11-26
Arteriocyte Medical Systems, Inc.
AMS300 - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
AMS100 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
AMS300 - MAGELLAN? Complete Disposable Kit2007-11-26
Arteriocyte Medical Systems, Inc.
AMS100 - MAGELLAN? Autologous Platelet Separator System2007-11-26
Arteriocyte Medical Systems, Inc.
AMS505 - MAGELLAN? Ratio Dispenser Kit2007-11-26

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