ClearanceBrief
Panels › General Hospital › Product code FPA · Class 2

Set, Administration, Intravascular

Regulation 880.5440

6510(k)s in 12 months (1,176 all time)
110recalls in 12 months (1,090 all time)
1,030recalls that name a 510(k)
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Top companies in FPA

DateFirm and productCodeLinked 510(k)
Mar 30, 2010Arrow International Inc
Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For Veterinary Use Only and with Two Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Polysulfone Stopcocks. An Intrav
Terminated
FPAK830755
Mar 30, 2010Arrow International Inc
IV Sets and Accessories, various configurations. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used
Terminated
FPAK830755
Mar 30, 2010Medical Product Specialist Inc dba MPS Acacia
Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte
Terminated
FPAK895367
Mar 30, 2010Medical Product Specialist Inc dba MPS Acacia
Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte
Terminated
FPAK895367
Mar 30, 2010Medical Product Specialist Inc dba MPS Acacia
Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Terminated
FPAK895367
Mar 30, 2010Medical Product Specialist Inc dba MPS Acacia
Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Terminated
FPAK895367
Mar 30, 2010Medical Product Specialist Inc dba MPS Acacia
Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte
Terminated
FPAK895367
Mar 30, 2010Medical Action Industries Inc
Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
Terminated
FPAK013621
Mar 30, 2010Medical Action Industries Inc
Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
Terminated
FPAK013621
Mar 30, 2010Medical Action Industries Inc
Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
Terminated
FPAK013621
Mar 9, 2010Hospira Inc.
Symbiq Pump Set, detachable, convertible pin piggyback w/backcheck valve, 3 prepierced reseal ports, Option-Lok, Latex-Free, Non-DEHP, 130 in. (330 cm), 15 drops/mL; a sterile Rx single use device; Ho
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Busines
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Business Park, Sligo, Irel
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, Latex-Free piggyback with backcheck valve, 3 prepierced Y-sites, 106 Inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa R
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, Latex-Free, Polyethylene-Lined tubing, piggyback with backcheck valve, 2 CLAVE Y-sites, 0.2 micron filter, 104 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospir
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. Made in Costa Ri
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced sites, 105 inch, Latex-Free, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA. made in Cost
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Latex-Free Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced Y-sites, 0.2 micron filter, 104 inch, non-DEHP, 15 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest,
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Symbiq Pump Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-DEHP, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospira, Finisklin Bu
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, 20 drops/mL; a sterile Rx single use device; Hospira Inc, Lake Forest, IL USA, Hospi
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 prepierced injection sites, 0.2 micron filter and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx single use dev
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 prepierced injection sites, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP, 60 drops/mL; a sterile
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 prepierced injection sites, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Fores
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 CLAVE ports, 0.2 micron filter and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake For
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 CLAVE ports, and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, non-DEHP, 15 drops/mL; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made i
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 104.5 inch with Polyethylene-Lined tubing, backcheck valve, 2 CLAVE ports, 0.2 micron filter, and OPTION-LOK, piggyback, 15 drops/mL; a sterile Rx device,
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL; a sterile Rx single patient device; Hospira Inc, Lake Forest, IL USA. M
Terminated
FPAK041550
Mar 9, 2010Hospira Inc.
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP 60 drops/mL; a sterile single patient u
Terminated
FPAK041550
Feb 26, 2010Bard Access Systems
Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set used to access surgi
Terminated
FPAK993848
Feb 26, 2010Bard Access Systems
Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico, Bard Access Systems, Inc., SLC, UT 84116. Safety IV administration set u
Terminated
FPAK993848
Feb 22, 2010Hospira Inc.
LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx sterile
Terminated
FPAK052722
Feb 22, 2010Hospira Inc.
LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. flui
Terminated
FPAK041550
Feb 2, 2010Becton Dickinson Medical Systems
MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
Terminated
FPAK013621
Feb 2, 2010Becton Dickinson Medical Systems
MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
Terminated
FPAK013621
Feb 2, 2010Becton Dickinson Medical Systems
MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,
Terminated
FPAK013621
Feb 2, 2010Becton Dickinson Medical Systems
BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
Terminated
FPAK013621
Feb 2, 2010Becton Dickinson Medical Systems
BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
Terminated
FPAK013621
Feb 2, 2010Becton Dickinson Medical Systems
BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
Terminated
FPAK013621
Feb 2, 2010Becton Dickinson Medical Systems
BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
Terminated
FPAK013621
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Y Type Blood Set with 170um Blood Filter, Injection Site, Spin Lock Connector, 131 in
Terminated
FPAK922637
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set for Epidural Admin w/Universal Spike, Microbore Tubing, Spin Lock Connector, 126 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Nitroglycerin Set w/Universal Spike & Spin Lock Connector, 135 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set with Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, Injection Site & Spin Lock Connector, 132 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Add On Set for Epidural Administration w/Microbore tubing & Sliding Spin Lock Connector, 88 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Syringe Add On Set w/Microbore Tubing, Injection Site, Spin Lock Connector, 88 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump Add On Set with Injection Site & Spin Lock Connector, 90 in
Terminated
FPAK904518
Jan 26, 2010B. Braun Medical, Inc.
Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure Limited Check Valve, 127 in
Terminated
FPAK904518

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