The following data is part of a premarket notification filed by Becton Dickinson Infusion Therapy Systems, Inc. with the FDA for Bd Posiflow Positive Displacement Valve.
Device ID | K050207 |
510k Number | K050207 |
Device Name: | BD POSIFLOW POSITIVE DISPLACEMENT VALVE |
Classification | Set, Administration, Intravascular |
Applicant | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Contact | Leslie Wood |
Correspondent | Leslie Wood BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-01-28 |
Decision Date | 2005-04-07 |
Summary: | summary |