Atlas FDA

BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100

FDA 510(k) clearance K013621 · decided 2002-04-16

Clearance details

K-number
K013621
Device name
BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
Decision
Substantially Equivalent
Date received
2001-11-05
Decision date
2002-04-16
Days to decision
162 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Sandy, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufa recall (Z-1317-2015)Becton Dickinson & Company2015-03-25
Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #38515 recall (Z-1073-2010)Medical Action Industries Inc2010-03-30
Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (B recall (Z-1074-2010)Medical Action Industries Inc2010-03-30
Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385 recall (Z-1075-2010)Medical Action Industries Inc2010-03-30
BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therap recall (Z-0750-2010)Becton Dickinson Medical Systems2010-02-02
BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinso recall (Z-0751-2010)Becton Dickinson Medical Systems2010-02-02
BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therap recall (Z-0752-2010)Becton Dickinson Medical Systems2010-02-02
BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Syst recall (Z-0753-2010)Becton Dickinson Medical Systems2010-02-02
MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150, recall (Z-0754-2010)Becton Dickinson Medical Systems2010-02-02
MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151 recall (Z-0755-2010)Becton Dickinson Medical Systems2010-02-02
MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164 recall (Z-0756-2010)Becton Dickinson Medical Systems2010-02-02