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) |
|---|---|---|---|
| Jun 8, 2015 | Smiths Medical Asd Inc Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Terminated |
FPA | K831087 |
| Apr 30, 2015 | Bard Access Systems PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215
The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling thro Terminated |
FPA | K073050 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 6" Trifurcated set with Bionectors, Product Code: BN-944
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" Standard Bore High Pressure Ext Set, Product Code: CMS-809
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 8" Standard Bore Ext Set, Product Code: BN-481
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore T-Port Set, Product Code: BN-448
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore Trifurcated Ext set, Product Code: BN-308
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. Bifircated Extension Set, Product Code: BN-828
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Apr 21, 2015 | Churchill Medical Systems, Inc. 6" Trifurcated Extension Set, Product Code: AMS-375-1
Accessory device used to administer medical fluids Terminated |
FPA | K021395 K070705 +1 |
| Mar 25, 2015 | Becton Dickinson & Company BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc.
An accessory to an intravascular administration set th Terminated |
FPA | K013621 |
| Mar 17, 2015 | Smiths Medical ASD, Inc. CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only. Terminated |
FPA | K040636 K843772 |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G Terminated |
FPA | K040527 K050600 +1 |
| Mar 13, 2015 | US Infusion Inc dba Trucare Biomedix-USA Medstream 81" (206 cm) 20 drop Universal Administration Sets.
Disposable IV infusion set with 3 year expiration date. Terminated |
FPA | K090012 |
| Feb 4, 2015 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set, Model No. 10015862
The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. Terminated |
FPA | K960280 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 17/110 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted inde Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 17/80 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 17/60 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 13/110 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted inde Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 13/80 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender II 13/60 10 + 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indep Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 17/110 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independen Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 17/80 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independent Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 17/60 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independent Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 13/110 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independen Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 13/80 10 pieces
Product Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independent Terminated |
FPA | K972135 |
| Dec 30, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Tender I 13/60 10 pieces
Product Usage: Usage:
Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted ind Terminated |
FPA | K972135 |
| Dec 12, 2014 | Medtronic MiniMed Inc. Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 6 Terminated |
FPA | K002138 K041545 |
| Nov 7, 2014 | Unomedical As SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; Su Terminated |
FPA | K041545 |
| Nov 7, 2014 | Unomedical As Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, Terminated |
FPA | K002138 K972135 |
| Nov 7, 2014 | Unomedical As Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Confor Terminated |
FPA | K120872 K972135 |
| Nov 7, 2014 | Unomedical As AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 Terminated |
FPA | K120872 K972135 |
| Nov 7, 2014 | Unomedical As Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Deta Terminated |
FPA | K041545 |
| Nov 7, 2014 | Unomedical As Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusio Terminated |
FPA | K120872 K972135 |
| Oct 6, 2014 | Biomedix, Inc. Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE Terminated |
FPA | K142097 |
| Sep 9, 2014 | Baxter Healthcare Corp ***Baxter***Non-DEHP***BURETROL Solution Set
105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve
3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile Terminated |
FPA | K123874 |
| Sep 9, 2014 | Baxter Healthcare Corp ***Baxter***BURETROL Solution Set***105" (2.7 m)
150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyr Terminated |
FPA | K123874 |
| Sep 9, 2014 | Baxter Healthcare Corp ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites
Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic Terminated |
FPA | K123874 |
| Jul 10, 2014 | Codan Us Corporation ColorSafe IV lines
Catalog No.(Model No.)
CS3000-R (76.7806),
CS400-R (76.7800),
CS408N-R (76.8000),
CS3000-B (76.7807),
B314 (25.7406),
CS400-B (76.7801),
CS408N-B (76.8001),
CS3000-O (76.7808),
C Terminated |
FPA | None listed |
| Jul 9, 2014 | CareFusion 303, Inc. SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A
14035457
14035485
14046894
14035458 Terminated |
FPA | K944320 |
| Jul 9, 2014 | B. Braun Medical, Inc. STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches Terminated |
FPA | K942988 |
| Jul 7, 2014 | RGI Medical Manufacturing, Inc. Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set
Product Usage:
Catheter extension set for high pressure procedures. Terminated |
FPA | K001599 |
| Apr 16, 2014 | CareFusion 303, Inc. SmartSite Extension Set, Model No. 20029E, intravascular administration set. Terminated |
FPA | K960280 |
| Mar 6, 2014 | Hospira Inc. *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Terminated |
FPA | K101677 |
| Feb 18, 2014 | B. Braun Medical, Inc. SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.
A device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted Terminated |
FPA | K060231 K760383 +3 |
| Feb 4, 2014 | CareFusion 303, Inc. Trifurcated Extension Set, model no. ME 1224.
Trifurcated Extension Set, model no. MP 9230. Terminated |
FPA | K051499 |
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