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)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Arrow 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 |
FPA | K830755 |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | K895367 |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | K895367 |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | K895367 |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | K895367 |
| Mar 30, 2010 | Medical Product Specialist Inc dba MPS Acacia Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte Terminated |
FPA | K895367 |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977. Terminated |
FPA | K013621 |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498. Terminated |
FPA | K013621 |
| Mar 30, 2010 | Medical Action Industries Inc Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B. Terminated |
FPA | K013621 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Mar 9, 2010 | Hospira 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 |
FPA | K041550 |
| Feb 26, 2010 | Bard 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 |
FPA | K993848 |
| Feb 26, 2010 | Bard 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 |
FPA | K993848 |
| Feb 22, 2010 | Hospira 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 |
FPA | K052722 |
| Feb 22, 2010 | Hospira 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 |
FPA | K041550 |
| Feb 2, 2010 | Becton Dickinson Medical Systems MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164 Terminated |
FPA | K013621 |
| Feb 2, 2010 | Becton Dickinson Medical Systems MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151 Terminated |
FPA | K013621 |
| Feb 2, 2010 | Becton Dickinson Medical Systems MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150, Terminated |
FPA | K013621 |
| Feb 2, 2010 | Becton Dickinson Medical Systems BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc. Terminated |
FPA | K013621 |
| Feb 2, 2010 | Becton Dickinson Medical Systems BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc. Terminated |
FPA | K013621 |
| Feb 2, 2010 | Becton 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 |
FPA | K013621 |
| Feb 2, 2010 | Becton Dickinson Medical Systems BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc. Terminated |
FPA | K013621 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Y Type Blood Set with 170um Blood Filter, Injection Site, Spin Lock Connector, 131 in Terminated |
FPA | K922637 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set for Epidural Admin w/Universal Spike, Microbore Tubing, Spin Lock Connector, 126 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Nitroglycerin Set w/Universal Spike & Spin Lock Connector, 135 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set with Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, Injection Site & Spin Lock Connector, 132 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Add On Set for Epidural Administration w/Microbore tubing & Sliding Spin Lock Connector, 88 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Syringe Add On Set w/Microbore Tubing, Injection Site, Spin Lock Connector, 88 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump Add On Set with Injection Site & Spin Lock Connector, 90 in Terminated |
FPA | K904518 |
| Jan 26, 2010 | B. Braun Medical, Inc. Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure Limited Check Valve, 127 in Terminated |
FPA | K904518 |
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