The following data is part of a premarket notification filed by Arteriocyte Medical Systems, Inc. with the FDA for 200 Micron Blood Component Filter And Syringe Adapter.
Device ID | K132905 |
510k Number | K132905 |
Device Name: | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER |
Classification | Set, Blood Transfusion |
Applicant | ARTERIOCYTE MEDICAL SYSTEMS, INC. 45 SOUTH STREET Hopkinton, MA 01748 |
Contact | Ann Charest |
Correspondent | David Yungvirt PHARMALINK TECHNICAL GROUP, LLC 20 F STREET, NW Washington, DC 20001 |
Product Code | BRZ |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-09-16 |
Decision Date | 2013-10-04 |
Summary: | summary |