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 |