Data / Medical devices / United States / Arteriocyte Medical Systems, Inc.
Arteriocyte Medical Systems, Inc.: FDA-registered device maker in Hopkinton, MA, United States, 9 510(k) clearances
Arteriocyte Medical Systems, Inc. is registered with the FDA (registration 3006788678) in Hopkinton, MA, United States. It lists 10 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 4, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006788678
- Address
- 42 South St, Hopkinton, MA, United States, 01748
- Owner or operator
- Arteriocyte Medical Systems, Inc. (10023471)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 26, 2007
- Registered through
- 2026
- Brand names listed
- AMS100 - MAGELLAN® Autologous Platelet Separator System, AMS300 - MAGELLAN® Complete Disposable Kit, AMS305 - MAGELLAN® Basic Disposable Kit, AMS310 - MAGELLAN® Complete One Source Kit, AMS350 - MAGELLAN® BASIC ONE SOURCE KIT, AMS505 - MAGELLAN® Ratio Dispenser Kit, AWL, Isto Biologics, BTI200 - AUTOSPIN MAGELLAN® Autologous Platelet Separator System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Biopsy Needle | FCG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Set, Blood Transfusion | BRZ | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2015 | K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-CORE | KNW | Substantially Equivalent | Biologic Therapies, Inc. | accessdata.fda.gov |
| October 4, 2013 | K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | BRZ | Substantially Equivalent | Arteriocyte Medical Systems, Inc. | accessdata.fda.gov |
| September 26, 2011 | K111838 | INQU PASTE MIX | MQV | Substantially Equivalent | Isto Technologies, Inc. | accessdata.fda.gov |
| August 29, 2011 | K103799 | INQU PASTE MIX PLUS | MQV | Substantially Equivalent | Isto Technologies, Inc. | accessdata.fda.gov |
| September 17, 2007 | K071428 | INQU | MQV | Substantially Equivalent | Isto Technologies, Inc. | accessdata.fda.gov |
| April 16, 2007 | K063359 | INQU | MQV | Substantially Equivalent | Isto Technologies, Inc. | accessdata.fda.gov |
| September 29, 2004 | K041830 | MAGELLAN RATIO DISPENSER KIT | FMF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
| August 12, 2002 | K021902 | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 | JQC | Substantially Equivalent | Medtronic Vascular | accessdata.fda.gov |
| April 3, 2002 | K020147 | MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP | FMF | Substantially Equivalent | Medtronic Perfusion Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Awl
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Syringe, Piston
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Biopsy Needle
Updated May 4, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.