FDA Registration
Active
🇺🇸 United States
Arteriocyte Medical Systems, Inc.
Reg #: 3006788678
·
FEI: 3006788678
·
Expires 2026
Products
10
Proprietary Names
39
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- Arteriocyte Medical Systems, Inc.
- Registration Number
- 3006788678
- FEI Number
- 3006788678
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 42 South St
- City
- Hopkinton
- State
- MA
- ZIP
- 01748
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041830
Owner / Operator
- Firm Name
- Arteriocyte Medical Systems, Inc.
- Operator Number
- 10023471
- Address
- 42 South Street
- City
- Hopkinton
- State
- MA
- Postal Code
- 01748
- Country
- US
- Correspondent
- Neil Kizer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2007-11-26 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2018-04-05 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2007-11-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-12-16 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2023-03-29 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-12-16 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2016-03-30 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2016-03-30 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2022-12-16 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2013-12-12 |
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 PASTE MIX PLUS
ENDOSS
AMS305 - MAGELLAN® Basic Disposable Kit
TRU300 - MAGELLAN® Complete Disposable Kit
TRU200 - MAGELLAN® Autologous Platelet Separator System
MDK300 - 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
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
LTN45 - MAGELLAN® Lightning Needle
AWL, Isto Biologics
MAR0 FS - 200 Micron Blood Component Filter and Syringe Adapter
MAR0Max - MAGELLAN® MAR0Max Quickdraw Kit
TRUMAR0 - MAGELLAN® TruMAR0 Convenience Kit
VetPRP - MAGELLAN® Basic Disposable Kit
MAR01-O - MAGELLAN® Surgical Tools for Erythrocyte and Marrow Preparation Kit
MAR0Max - MAGELLAN® Complete Disposable Kit
BTI200 - AUTOSPIN MAGELLAN® Autologous Platelet Separator System
MAR01 - MAGELLAN® Surgical Tools for Erythrocyte and Marrow Preparation Kit
Turbine Autologous Concentration Kit
MAR01-O-80 Magellan® Surgical Tools for Erythrocyte and Marrow Preparation Kit
MAR01-O-105 Magellan® Surgical Tools for Erythrocyte and Marrow Preparation Kit
MAR01-O-25 Magellan® Surgical Tools for Erythrocyte and Marrow Preparation Kit
MAR01-O-45 Magellan® Surgical Tools for Erythrocyte and Marrow Preparation Kit
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198