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)
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP Minivolume Extension Set, product code 1C8690; An Rx sterile, nonpyrogenic fluid pathway, 8'', 0.22 mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60
Terminated
FPAK811078
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7'', 0.3 mL Vol, with Male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerf
Terminated
FPAK925126
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22'', 0.9 mL Vol, with injection site and Stationary Swivel Lock T-Connector; Baxter H
Terminated
FPAK921899
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8483; An Rx sterile, nonpyrogenic fluid pathway, 18', 1.3 mL Vol. with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer
Terminated
FPAK964850
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstream High Pressure Exte
Terminated
FPAK925126
K964850
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8412; 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
Mar 24, 2006Baxter Healthcare Corp.
Baxter Minivolume Extension Set, product code 1C8400; An Rx sterile, nonpyrogenic fluid pathway, 13.0'', 0.4 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.
Terminated
FPAK811078
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.6 mL Vol., with injection site and male Luer Lock adapter; Baxter Healthcare
Terminated
FPAK925126
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock adapter; Baxter Health
Terminated
FPAK925126
Mar 24, 2006Baxter Healthcare Corp.
Baxter Anesthesia Set, product code 2C9216; An Rx sterile, nonpyrogenic fluid pathway, 72'', 1.7 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Terminated
FPAK880733
Mar 24, 2006Baxter Healthcare Corp.
Baxter Mini-Infuser Microbore Extension Set, product code 2C9203; An Rx sterile, nonpyrogenic fluid pathway, 61'', 0.9 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, I
Terminated
FPAK811078
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.5 mL Vol., with injection site and male Luer Lock adapter with Re
Terminated
FPAK925126
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL
Terminated
FPAK811463
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3348; An Rx sterile, nonpyrogenic fluid pathway, 60'', 0.5mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 6
Terminated
FPAK811463
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.38mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL
Terminated
FPAK811463
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 1.0 mL Vol., with 1 Interlink T-connector injection sites and male Luer Lock
Terminated
FPAK921899
K925126
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a male Luer Lock adapt
Terminated
FPAK791496
K915390 +1
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP I.V. Catheter Extension Set, product code 2N1194; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 0.3 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield,
Terminated
FPAK811078
Mar 24, 2006Baxter Healthcare Corp.
Baxter Minivolume Extension Set, product code 2C5681; An Rx sterile, nonpyrogenic fluid pathway, 6.4'', 0.4 mL Vol., with male Luer Slip T-Connector; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPAK811078
Mar 24, 2006Baxter Healthcare Corp.
Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191; An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield,
Terminated
FPAK791496
Mar 24, 2006Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N8371; An Rx sterile, nonpyrogenic fluid pathway, 6.0'', 1.0 mL Vol., with 2 Luer Activated Valves and a male Luer Lock ad
Terminated
FPAK003225
Mar 18, 2006Smiths Medical MD, Inc.
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, n
Terminated
FPAK811933
K991599
Mar 18, 2006Smiths Medical MD, Inc.
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile,
Terminated
FPAK811933
K991599
Mar 18, 2006Smiths Medical MD, Inc.
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps.---- Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve set for Secondary (
Terminated
FPAK811933
K991599
Feb 8, 2006Hospira Inc.
Hospira Transpac IV Monitoring Kit, 60 inch disposable transducer monitoring kit with second stopcock by transducer, continuous flush device and drip chamber; Made in Costa Rica, Hospira, Inc., Lake F
Terminated
FPAK813464
K831506
Feb 8, 2006Hospira Inc.
LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and 2 Clave Ports, Piggyback with Option-Lok; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.
Terminated
FPAK832755
Feb 8, 2006Hospira Inc.
Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A.
Terminated
FPAK830014
Nov 26, 2005Baxter Healthcare Corp.
Buretrol Solution Sets, a sterile fluid pathway of various lengths, 60 drops/mL, with 150 mL Burette Ball Valve, 2 injection sites and male luer lock adapter; Baxter Healthcare Corporation, Deerfield,
Terminated
FPAK984381
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3716; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1-1/2'', Total Volum
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3714; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 1'', Total Volume 0.
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3712; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 1'', Total Volume 0.
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3710; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 1'', Total Volume 0.
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3709; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 22, Needle Length 3/4'', Total Volume
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3707; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 20, Needle Length 3/4'', Total Volume
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3706; An Rx sterile, nonpyrogenic fluid pathway with Interlink Y-Injection Site, Needle Gauge 19, Needle Length 3/4'', Total Volume
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Huber Needle Extension Set, product code 2N3703; An Rx sterile, nonpyrogenic fluid pathway with Needle Gauge 22, Needle Length 3/4'', Total Volume 0.40 mL, Total Length 9''; Ba
Terminated
FPAK961495
Aug 30, 2005Baxter Healthcare Corp.
Baxter Extension Set, product code 2C9219; An Rx sterile, nonpyrogenic fluid pathway, 61'', 1.4 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Terminated
FPAK880733
Aug 30, 2005Baxter Healthcare Corp.
Baxter Tamper Resistant Anti-Siphon Combination Set, 101'', product code 2L3507; An Rx sterile, nonpyrogenic fluid pathway, 101'', 2.5 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporati
Terminated
FPAK840760
K880733
Aug 30, 2005Baxter Healthcare Corp.
Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 96'', product code 2C9206; An Rx sterile, nonpyrogenic fluid pathway, 96'', 1.6 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation,
Terminated
FPAK880733
Aug 30, 2005Baxter Healthcare Corp.
Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 60'', product code 2C9205; An Rx sterile, nonpyrogenic fluid pathway, 60'', 1.2 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation,
Terminated
FPAK880733
Aug 30, 2005Baxter Healthcare Corp.
Baxter Mini-Infuser Microbore Extension Set, product code 2C9201; An Rx sterile, nonpyrogenic fluid pathway, 61'', 0.5 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60
Terminated
FPAK860272
Aug 30, 2005Baxter Healthcare Corp.
Baxter Minivolume Extension Set, 36'', product code 2C5685; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.9 mL Vol., with a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60
Terminated
FPAK860272
Aug 30, 2005Baxter Healthcare Corp.
Baxter Minivolume Extension Set, 72'', product code 2C5687; An Rx sterile, nonpyrogenic fluid pathway, 72'', 1.6 mL Vol., with a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60
Terminated
FPAK860272
Aug 30, 2005Baxter Healthcare Corp.
Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter;
Terminated
FPAK791496
K925126
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Terminated
FPAK791496
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
FPAK925126
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol., with 0.22 Micron Downstream Filter, 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporat
Terminated
FPAK811078
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8462; 16'', 4.2 mL Vol., with 0.22 Micron Downstream High Pressure Extended Life Filter, 2 injection sites and a male Luer Lock adapter
Terminated
FPAK964850
Aug 6, 2005Baxter Healthcare Corp.
Baxter Interlink System Minivolume Extension Set, product code 1C8290; 11'', 0.86 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A
Terminated
FPAK925126
Aug 6, 2005Baxter Healthcare Corp.
Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette, product code 560500-100; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Mexico
Terminated
FPAK002679

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