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)
Top companies in FPA
| Company | 510(k)s | Recalls |
|---|---|---|
| B.Braun Medical, Inc. | 23 | 234 |
| Baxter Healthcare Corp | 67 | 151 |
| Icu Medical, Inc. | 27 | 187 |
| Hospira, Inc. | 14 | 109 |
| Smiths Medical MD, Inc. | 4 | 37 |
| Churchill Medical Systems, Inc. | 7 | 32 |
| CME America, LLC | 0 | 38 |
| Abbott Laboratories | 30 | 0 |
| Y | 28 | 0 |
| Carefusion, Inc. | 1 | 25 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2020 | ICU Medical, Inc. 142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948;(01)10887709089393( Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709088518(17)241101(30)25(10)4475764
(01)10887709088518(17)25020 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case.
UDI:(01)10887709088501(17)250201(30)25(10)4733705.
The Intravascular A Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709087153(17)250101(30)50(10)4556715;
(01)10887709087153(17)250101(30)50(10)4579939;
(01)108 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case. UDI:(01)10887709086224(17)250201(30)50(10)4718658.
The Intravascular Adminis Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641.
The Intravascular Administ Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case.
UDI:(01)10887709089508(17)250101(30)25(10)4548244.
The Intrava Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(3 Terminated |
FPA | K080077 |
| Jul 6, 2020 | ICU Medical, Inc. 113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way NanoClave" Stopcocks, Spin Luer w/ Filter Cap, 2 Ext.1 unit per pouch, 50 multivac Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709070902(17)2 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.
UDI:(01)10887709084435(17)250101(30)50(10)4549131.
The Intrav Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579.
The Intravascular Administration Set is a single use, sterile, non-pyrogenic device Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case.
UDI:(01)10840619082533(17)250101(30)50(10)4605138.
The Intravascular Administration Set is a Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)453667 Terminated |
FPA | K080077 |
| Jul 6, 2020 | ICU Medical, Inc. NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842.
The ICU Medical Clave Stopcock is a device used to administer or wi Terminated |
FPA | K080077 |
| Jul 6, 2020 | ICU Medical, Inc. 5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709097329(17)25 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533;
(01)10887709090245(17)25010 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709090238(17)250101(30)50(10)4572966;
(01)108877090902 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709049496(17)250101(30)50(10)4603265;
(01 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)10887709085210(17)250101(30)50(10)4572801;
(01)10887709085227(17)25 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit per pouch, 50 multiva Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709080703(17)250101(30)50(10)4603290.
The Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887 Terminated |
FPA | K100576 |
| Jul 6, 2020 | ICU Medical, Inc. 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 multivac pouches per case.UDI:(01)10887709077671(17)250101(30)50(10)4557524.
Th Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709075334(17 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp, Luer Lock; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709071 Terminated |
FPA | K100576 |
| Jul 6, 2020 | ICU Medical, Inc. 12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouches per case. UDI: (01)10887709070100(17)250101(30)50(10)4572779; (01)108877090701 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case.
UDI:(01)10887709069340(17)250101(30)50(10)4558471.
The Intravascul Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709085005(17)250101(30)50(10)4 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Connector (Purple Ring), Rotating Luer; unit per pouch, 50 multivac pouches per case Terminated |
FPA | K100576 |
| Jul 6, 2020 | ICU Medical, Inc. 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Connector, 4 Clamps, Rotating Luer. UDI:(01)10887709067049(17)250101(30)50(10)45908 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Trifuse Ext Set w/2 MicroClave Clear, 0.2 Micron Filter, Rotating Luer. 1 unit per Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI: (01)10887709065069(17)250101(30)50(10)4590843;(01)10887709065069(17) Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.
UDI:(01) Terminated |
FPA | K100576 |
| Jul 6, 2020 | ICU Medical, Inc. 9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clamps, Rotating Luer. 1 unit per pouch, 50 multivac pouches per ca Terminated |
FPA | K100576 |
| Jul 6, 2020 | ICU Medical, Inc. 5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053028(17)250101(30)50(10)4603262.
Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053004(17)250101(30)50(10)4568886;(01)1088 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case
UDI:(01)10887709052953(17) Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri-Connector, NanoClave T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI:(01) Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051055(17)250101(30)50(1 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)50(10)4572718;
(01)1 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case;
UDI: (01)10887709052809(17)250101(30)50(10)4599980. Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:
(01)10887709051031(17)250101(30)50(10)4 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case;
UDI:(01)10887709051024(17)250101(30)50(10)4603240;(01)10887709 Terminated |
FPA | K964435 |
| Jul 6, 2020 | ICU Medical, Inc. NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754
CLAVE Neutron is a normally cl Terminated |
FPA | K100434 |
| Jun 26, 2020 | Codan US Corporation CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA. Terminated |
FPA | K033301 |
| Apr 9, 2020 | BD SWITZERLAND SARL BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-s Terminated |
FPA | K811885 |
| Apr 9, 2020 | BD SWITZERLAND SARL BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Terminated |
FPA | K811885 |
| Apr 9, 2020 | BD SWITZERLAND SARL BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Terminated |
FPA | K811885 |
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