510(k) K970855 ยท FPA Set, Administration, Intravascular
CLAVE CONNECTOR
| Applicant | Icu Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | Mar 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2022 | ICU Medical, Inc. MicroClave Clear Neutral Connector;
MicroClave Clear Connector;
MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set Open, Classified |
FPD | None listed |
| Jan 9, 2014 | ICU Medical, Inc. NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769
The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessor Terminated |
FPA | None listed |
| Jan 9, 2014 | ICU Medical, Inc. 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector,
Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002
The ICU Needleless Connector is a single use, sterile, non-pyrogenic device Terminated |
FPA | None listed |
| Jan 9, 2014 | ICU Medical, Inc. 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave, 3
Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029
The ICU Needleless Connector is a single use, sterile, non-pyrogenic devic Terminated |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jan 9, 2014 | ICU 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 |
FPA | None listed |
| Jun 27, 2003 | Abbott Laboratories HPD/ADD I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, IL 60064 USA; 22 different sets listed in the code information section below. Please Note: items p, q & r (li Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.