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)
Feb 3, 2014CareFusion 303, Inc.
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The ne
Terminated
FPAK960280
Jan 24, 2014Navilyst Medical, Inc.
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog
Terminated
FPAK100720
K122767 +1
Jan 23, 2014Churchill Medical Systems, Inc.
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Terminated
FPAK021395
Jan 9, 2014ICU Medical, Inc.
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. The ICU Needleless Connector is a single use, ste
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyr
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, no
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an acce
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
120" 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoClave T-Connector, Rotating Luer, 1 Ext, Part No. A1000, Item No. SC124 The ICU Needleless Connector is a singl
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device i
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connecto
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device in
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyroge
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Needleless Connector is a single use, sterile, non-pyrogen
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device i
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device in
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for u
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
78" Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is a single use, steri
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use,
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleles
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 The ICU Needleless Connector is a single use, ster
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administra
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The ICU Needleless Connector is a single use, sterile, non-pyrogeni
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device i
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic devic
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector is a single use, ste
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, sterile, non-pyrogeni
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device inten
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave, Part No. A1000, Item No. A1078 The ICU Needleless Connector is a
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as a
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intend
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intend
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
78" Ext Set w/Check Valve, CLAVE Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave, NanoClave T-Connector, 4 Clamps, Rotating Luer, 3 Ext, Part No. A1000, Item No. A1026 The ICU Needleless Connector is a
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Connector is a single u
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, no
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic devi
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device inte
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
17 cm (7'') Ext Set w/NanoClave, 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1097 The ICU
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave, NanoClave TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needle
Terminated
FPAK970855
Jan 9, 2014ICU Medical, Inc.
183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave , NanoClave T-Connector, Rotating Luer, Part No. A1000, Item No.
Terminated
FPAK970855

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