Arteriocyte Medical Systems, Inc.

FDA Device Registration & Listing · Hopkinton, MA, US · Registration 3006788678

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
3006788678
FEI Number
3006788678
Entity Name
Arteriocyte Medical Systems, Inc.
City/State/Country
Hopkinton, MA, US
Establishment Address
42 South St, Hopkinton, MA 01748, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Arteriocyte Medical Systems, Inc. (Owner Number: 10023471)
Owner / Operator Contact Address
42 South Street, Hopkinton, MA 01748, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K141910
PMA Number
N/A

All Registered Proprietary Names

AMS505 - MAGELLAN® Ratio Dispenser Kit AMS350 - MAGELLAN® BASIC ONE SOURCE KIT InQu INQU PASTE MIX AMS300 - MAGELLAN® Complete Disposable Kit AMS100 - MAGELLAN® Autologous Platelet Separator System Isto Biologics InQu INQU PASTE MIX PLUS ENDOSS AMS305 - MAGELLAN® Basic Disposable Kit TRU300 - MAGELLAN® Complete Disposable Kit AMS100 - MAGELLAN® Autologous Platelet Separator System TRU200 - MAGELLAN® Autologous Platelet Separator System MDK300 - MAGELLAN® Complete Disposable Kit AMS300 - MAGELLAN® Complete Disposable Kit TRU310 - MAGELLAN® Complete One Source Kit MAG200 - MAGELLAN® Autologous Platelet Separator System AMS310 - MAGELLAN® Complete One Source Kit TRU100 - MAGELLAN® Autologous Platelet Separator System AMS505 - MAGELLAN® Ratio Dispenser Kit Precise Diamond - 60 mL LP Kit Precise Separation Canister Precise Diamond - 120 mL LP Kit Precise Cell Concentration System Precise Sapphire - 120 mL LR Kit Precise Sapphire - 60 mL LR Kit Fibrant Instrument Kit Precise Separation Canister Precise Cell Concentration System LTN45 - MAGELLAN® Lightning Needle™

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-11-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-04-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-04-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-11-26
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2007-11-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2022-12-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-04-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-04-05
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-11-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-11-26
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2023-03-29
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-12-16
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2026-06-10
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2016-03-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2016-03-30

Official Correspondent

Neil Kizer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arteriocyte Medical Systems, Inc.
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
K880350 Honway International Co. YUE/FA DISPOSABLE SYRINGE 1988-02-16
K003571 Terumo Medical Corp. SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE 2001-02-12
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04 Liberty Medical Supplies 2
Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006788678. Last updated year: 2026. Please use registration number 3006788678 when referencing this establishment in official correspondence.
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