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 19, 2012Medtronic MiniMed
Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6 versus 9mm)
Terminated
FPAK030149
Jan 19, 2012Hospira Inc.
Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc.,
Terminated
FPAK101677
Jan 17, 2012Smiths Medical ASD, Inc.
CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to
Terminated
FPAK991301
Jan 11, 2012ConMed Corporation
STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 60 Drops/cc, 84 length, Catalog/REF No. P-S2V-60 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 60 Drops/cc, 84" length, Catalog/REF No. P-S2V-60, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, U
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller (Needle-Free), 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 52
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Pumpette Primary Administration Set Gravity Flow Compensating Controller, 20 Drops/cc, 84" length, Catalog/REF No. P-S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, U
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Pumpette Extension Set Gravity Flow Compensating Controller (Needle-Free), 12 length, Catalog/REF No. P-S2-12 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 135
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/cc, 84 in. length, Catalog/REF No. S2V-60 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA,
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Primary Administration Set Gravity Flow Controller, 60 Drops/cc, 84 in. length, Catalog/REF No. S2V-60, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- Th
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/cc, 13 in. length, Catalog/REF No. S2-20 MD, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a dis
Terminated
FPAK905498
Jan 11, 2012ConMed Corporation
STAT 2 Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/cc, 84 in. length, Catalog/REF No. S2V-20 N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA,
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Primary Administration Set Gravity Flow Controller, 20 Drops/cc, 84 in. length, Catalog/REF No. S2V-20, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- Th
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Extension Set Gravity Flow Controller (Needle-Free), 12 in. length, Catalog/REF No. S2-12N, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disp
Terminated
FPAK964844
Jan 11, 2012ConMed Corporation
STAT 2 Extension Set Gravity Flow Controller, 12 in. length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13502 --- This is a disposable device w
Terminated
FPAK964844
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter, Length 95" (2.4 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for t
Terminated
FPAK932301
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, Length 86" (2.2 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the
Terminated
FPAK932301
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the
Terminated
FPAK961225
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration
Terminated
FPAK940867
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the pati
Terminated
FPAK860272
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Injection Sites, Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the
Terminated
FPAK860272
Jan 11, 2012Baxter Healthcare Corp.
Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to the
Terminated
FPAK925126
Jan 11, 2012ICU Medical, Inc.
IV Start Kits Convenience kit for starting IVs. Triad wipes are packaged within the sterile barrier and would require compromising the barrier to replace the wipe.
Terminated
FPAK033290
Jan 11, 2012ICU Medical, Inc.
Orbit and Orbit Micro Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit devices. Our device is within its own separate sterile package and the wipes are packaged with our d
Terminated
FPAK033290
Nov 25, 2011Hospira Inc.
Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administ
Terminated
FPAK101677
Nov 17, 2011Medtronic Minimed
Medtronic MiniMed paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum.
Terminated
FPAK051264
Aug 3, 2011Baxter Healthcare Corp.
Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. Baxter Healthcare Corporation. A sterile, single use, nonpyrogenic fluid pathway for use with rigid nonvente
Terminated
FPAK961225
Jul 15, 2011Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathway; 200 sets per cas
Terminated
FPAK925126
Jun 29, 2011Carefusion 303, Inc.
MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vas
Terminated
FPAK051499
Jun 29, 2011Baxter Healthcare Corp.
Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxt
Terminated
FPAK925058
Feb 16, 2011Churchill Medical Systems, Inc.
Winged Infusion Set with 90 degree Huber Needle and Y Injection Site Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683 Item # FIY-2210 Intended use: Intravascular Administratio
Terminated
FPAK020544
Feb 16, 2011Churchill Medical Systems, Inc.
FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322 Intended use: Intravascular Administration Set
Terminated
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1 Intended use: Intravascular Administration Set
Terminated
FPANone listed
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems 14"Extension Set with SmartSite Injection Item # 43000E Intended use: Intravascular Administration Set
Terminated
FPAK021395
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems Fluid Transfer Set; Sterile Item # AMS-451 Intended use: Intravascular Administration Set
Terminated
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
Walkmed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; Manufactured for: WalkMed Infusion 96 Inverness Drive East, Suite 1 Englewood, CO 80112 Item # T100-000F Int
Terminated
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234 The Lifeguard
Terminated
FPAK013871
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with male/Female Luer Locks Slide Clamps & 0.2 Micron Filter Item Number: AMS-944 Intended use: Intravascular Administration
Terminated
FPAK021395
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical 78" Stopcock Extension Set with male/female red cap; item # AMS-464-1 Intended use: Intravascular Administration Set
Terminated
FPAK021395
Feb 16, 2011Churchill Medical Systems, Inc.
WalkMed Infusion 100" 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow Protection Clip Manufactured for WalkMed Infusion 96 Inverness Drive East Suite 1 Engelwood, CO 80112 Item #
Terminated
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
Churchill Medical Systems Central Line Dressing Kit; Item # AMS-8316CP-1 Intended use: Intravascular Administration Set
Terminated
FPANone listed
Feb 16, 2011Churchill Medical Systems, Inc.
WalkMed Infusion Triton 90" 20 drop IV Administration Set; Manufactured for Walked Infusion 96 Inverness Drive East, Suite 14 Englewood, CO 80112 Item # T090-000 Intended use: Intravascular Administ
Terminated
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and 0.22 Intended use: Intravascular Administration Set
Terminated
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site Item # T090-000V Intended use: Intravascular Administration Set
Terminated
FPAK011336
Feb 16, 2011Churchill Medical Systems, Inc.
WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W Intended use: Intravascular Administration Set
Terminated
FPAK011336
Dec 1, 2010Baxter Healthcare Corp.
Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product
Terminated
FPAK970438
Oct 27, 2010Baxter Healthcare Corp.
Baxter Catheter Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter, Volume 1.0 mL, Length 6" (15 cm); an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPAK003225
Oct 27, 2010Baxter Healthcare Corp.
Baxter Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx ste
Terminated
FPAK964918
Oct 27, 2010Baxter Healthcare Corp.
Baxter Non-DEHP Y-Type Catheter Extension Set, 6.6" (16.8 cm)., 1.1 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile devi
Terminated
FPAK964918
Oct 27, 2010Baxter Healthcare Corp.
Baxter Non-DEHP I.V. Catheter Extension Set, 6.0" (15.2 cm), 0.5 mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male Luer Lock Adapter with Retractable Collar; an Rx sterile device;
Terminated
FPAK964918

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