The following data is part of a premarket notification filed by Arteria Medical Science, Inc. with the FDA for Arteria Blood Filter.
Device ID | K021293 |
510k Number | K021293 |
Device Name: | ARTERIA BLOOD FILTER |
Classification | Filter, Infusion Line |
Applicant | ARTERIA MEDICAL SCIENCE, INC. 22 HILL ST. Newburyport, MA 01950 |
Contact | Alan Hinton |
Correspondent | Alan Hinton ARTERIA MEDICAL SCIENCE, INC. 22 HILL ST. Newburyport, MA 01950 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-23 |
Decision Date | 2002-08-22 |
Summary: | summary |