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)
Jun 5, 2009B. Braun Medical, Inc.
Ultrasite IV Administration Set with Universal Spike, three Backcheck Valves, three Ultrasite Injection Sites and Spin-Lock Connector, Catalog #470007. For use with Secondary Container.
Terminated
FPAK955585
Jun 5, 2009B. Braun Medical, Inc.
Primary IV Set with Universal Spike, Backcheck Valve, 3 Ultrasite Injection Sites and Spin-Lock Connector, Catalog # 375100. For use with Secondary Container.
Terminated
FPAK955585
Jun 5, 2009B. Braun Medical, Inc.
Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For us
Terminated
FPAK904518
K955585
Jun 5, 2009B. Braun Medical, Inc.
IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. For use with Secondary Container.
Terminated
FPAK955585
Apr 20, 2009Smiths Medical MD, Inc.
CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Amb
Terminated
FPAK843772
Oct 24, 2008B. Braun Medical, Inc.
Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5 in. The product is shipped 100 units per carton.
Terminated
FPAK955585
Sep 23, 2008B. Braun Medical, Inc.
Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog number 375113. The product is shipped 20 units per carton. The product is for use after ac
Terminated
FPAK781744
K921860
Sep 23, 2008B. Braun Medical, Inc.
Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set. Item/Catalog number 375059. The product is shipped 20 units per car
Terminated
FPAK781744
K790062 +1
Sep 23, 2008B. Braun Medical, Inc.
Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after act
Terminated
FPAK781744
K790062 +1
Sep 23, 2008B. Braun Medical, Inc.
Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The product is shipped 20 units per carton. The product is for use afte
Terminated
FPAK781744
K921860 +1
Sep 23, 2008B. Braun Medical, Inc.
Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlo
Terminated
FPAK781744
K904518 +1
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra
Terminated
FPAK915678
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra
Terminated
FPAK915678
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contras
Terminated
FPAK915678
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contras
Terminated
FPAK915678
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra
Terminated
FPAK915678
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra
Terminated
FPAK915678
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra
Terminated
FPAK915678
Sep 11, 2008Merit Medical Systems, Inc.
Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, processing or repacking., Merit Medical Systems, Inc., South Jordan, Utah 84095. Product is used to transfer contra
Terminated
FPAK915678
Feb 13, 2008Smiths Medical MD, Inc.
Smiths CADD Yellow Medication Cassette Reservoirs with Flow Stop, Clamp and Female Luer, 100 ml, Reorder No. 21-7300-24, Nonvented stopper included, Sterile, Smiths Medical, St. Paul, MN 55112
Terminated
FPAK040636
Nov 8, 2007Cardinal Health 303 Inc DBA Alaris Products
Texium Closed Male Luer (CML), Model Number 10012241, Cardinal Health, SanDiego, CA.
Terminated
FPAK053049
Aug 30, 2007Smiths Medical MD, Inc.
Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4695-24A, REF 21-7002-24, Sterile EO, Made in Mexico Smith Medical MD, Inc. St Paul, MN 5
Terminated
FPAK843772
Aug 30, 2007Smiths Medical MD, Inc.
Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC 4694-24A, REF 21-7001-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, MN 55112
Terminated
FPAK843772
Aug 30, 2007Smiths Medical MD, Inc.
Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Made in Mexico Smith Medical MD, Inc. St Paul, M
Terminated
FPAK843772
Aug 22, 2007Carmel Pharma, Inc.
PhaSeal, Protector 50, Item No. 50, US Order No. 10310
Terminated
FPAK001368
Aug 22, 2007Carmel Pharma, Inc.
PhaSeal, Protector 21, Item No. 21, US Order No. 22020
Terminated
FPAK001368
Aug 22, 2007Carmel Pharma, Inc.
PhaSeal Injector Luer Lock, Item No. 31, US Order No. 10310
Terminated
FPAK001368
Aug 22, 2007Carmel Pharma, Inc.
PhaSeal, Protector 14, Item No. P14, US Order No. 21320
Terminated
FPAK001368
Aug 18, 2007Arizant Healthcare, Inc
Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit.
Terminated
FPAK973741
Aug 18, 2007Arizant Healthcare, Inc
Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24200. For use with a Ranger warming unit.
Terminated
FPAK973741
Aug 16, 2007ICU Medical, Inc.
Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291
Terminated
FPAK033290
Aug 7, 2007Curlin Medical Llc
Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets.
Terminated
FPAK981816
May 31, 2007B. Braun Medical, Inc.
Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets.
Terminated
FPAK904518
K955585
May 31, 2007B. Braun Medical, Inc.
Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets.
Terminated
FPAK904518
K955585
Mar 14, 2007Baxter Healthcare Corp.
Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for us
Terminated
FPAK981792
Mar 14, 2007Baxter Healthcare Corp.
Baxter Interlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer loc
Terminated
FPAK981792
Mar 14, 2007Baxter Healthcare Corp.
Baxter Clearlink System Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP 12 inch pump segment, 0.22 micron downstream high pressure filter, Luer activated valve,
Terminated
FPAK003225
K981792
Feb 27, 2007Hospira Inc.
LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light R
Terminated
FPAK830014
Dec 30, 2006Rymed Technologies, Inc.
RYM-5001 InVision-Plus Neutral Displacement I.V. Connector, packaged 100 units per box, 5 boxes per case (500 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies,
Terminated
FPAK991653
Dec 30, 2006Rymed Technologies, Inc.
RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin
Terminated
FPAK991653
Dec 30, 2006Rymed Technologies, Inc.
RYM-5000 InVision-Plus Neutral Displacement I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies,
Terminated
FPAK991653
Dec 6, 2006Smiths Medical ASD, Inc.
Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)
Terminated
FPABK860023
Dec 6, 2006Smiths Medical ASD, Inc.
Level 1 Normothermic I.V. Fluid Administration Set REF D-60HL
Terminated
FPABK860023
Mar 24, 2006Baxter Healthcare Corp.
Baxter Minivolume Extension Set, product code JC9944; An Rx sterile, nonpyrogenic fluid pathway, 8'', 0.4 mL Vol., with Luer Activated Valve; Baxter Corporation, Toronto, Ontario, Canada; Made in Cana
Terminated
FPANone listed
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream Filter and male Luer
Terminated
FPAK925126
K964850
Mar 24, 2006Baxter Healthcare Corp.
Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8739; An Rx sterile, nonpyrogenic fluid pathway, 8.0'', 0.6 mL Vol., with Luer Activated Valve for IV Access and male Luer Loc
Terminated
FPAK003225
Mar 24, 2006Baxter Healthcare Corp.
Baxter Clearlink System Non-DEHP Minivolume Extension Set, product code 1C8705; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 0.33 mL Vol., with Luer Activated Valve for IV Access and male Luer Lo
Terminated
FPAK003225
Mar 24, 2006Baxter Healthcare Corp.
Baxter Y-Type Minivolume Extension Set, product code 1C8689; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 6
Terminated
FPAK811078
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter H
Terminated
FPAK925126
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System 3-Lead Extension Set, product code 1C8442; An Rx sterile, nonpyrogenic fluid pathway, 6'', 1.6 mL Vol., with 2 Interlink Injection Sites and a Male Luer Lock adapter; Baxter He
Terminated
FPAK915390

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