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)
Get daily alerts for FPASample briefCSV

Top companies in FPA

DateFirm and productCodeLinked 510(k)
Jun 8, 2015Smiths 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
FPAK831087
Apr 30, 2015Bard 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
FPAK073050
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill 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
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill 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
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
8" Standard Bore Ext Set, Product Code: BN-481 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Apr 21, 2015Churchill Medical Systems, Inc.
6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids
Terminated
FPAK021395
K070705 +1
Mar 25, 2015Becton 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
FPAK013621
Mar 17, 2015Smiths Medical ASD, Inc.
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Terminated
FPAK040636
K843772
Mar 13, 2015Bard 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
FPAK040527
K050600 +1
Mar 13, 2015US 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
FPAK090012
Feb 4, 2015CareFusion 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
FPAK960280
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 30, 2014Roche 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
FPAK972135
Dec 12, 2014Medtronic 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
FPAK002138
K041545
Nov 7, 2014Unomedical 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
FPAK041545
Nov 7, 2014Unomedical 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
FPAK002138
K972135
Nov 7, 2014Unomedical 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
FPAK120872
K972135
Nov 7, 2014Unomedical 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
FPAK120872
K972135
Nov 7, 2014Unomedical 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
FPAK041545
Nov 7, 2014Unomedical 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
FPAK120872
K972135
Oct 6, 2014Biomedix, 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
FPAK142097
Sep 9, 2014Baxter 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
FPAK123874
Sep 9, 2014Baxter 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
FPAK123874
Sep 9, 2014Baxter 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
FPAK123874
Jul 10, 2014Codan 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
FPANone listed
Jul 9, 2014CareFusion 303, Inc.
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Terminated
FPAK944320
Jul 9, 2014B. Braun Medical, Inc.
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Terminated
FPAK942988
Jul 7, 2014RGI Medical Manufacturing, Inc.
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Terminated
FPAK001599
Apr 16, 2014CareFusion 303, Inc.
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Terminated
FPAK960280
Mar 6, 2014Hospira 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
FPAK101677
Feb 18, 2014B. 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
FPAK060231
K760383 +3
Feb 4, 2014CareFusion 303, Inc.
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
Terminated
FPAK051499

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.