510(k) K983559 ยท FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
| Applicant | Icu Medical, Inc., San Clemente CA, US |
| Decision | Substantially Equivalent, Dec 24, 1998 |
| Received | Oct 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983559
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | ICU Medical, Inc. 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795 Open, Classified |
FJK | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 119" Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to bloo Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 185 cm (73") Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave, Clave, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyroge Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunc Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use a Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave, Check Valve, Y-Connector, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, steri Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. Lopez Valve w/Red Cap, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devic Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. Lopez Valve, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for nee Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyro Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intende Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave w/Remv 3 Gang 1o2 Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, no Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave, Rotating Luer, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non- Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as a Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device in Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended fo Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Rotating Luer, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device int Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrog Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter, Hand Pump, Inj Site, Remv 3 Gang 4-Way Stopcocks w/Baseplate, 2 Clave, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Co Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, no Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer w/Filter Cap, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrog Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave Clear, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogeni Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave Clear, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile
The blood tubing accessory with CLAVE Con Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile
The blood tubing accessory with CLAVE Connector is a single use, Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave, Rotating Luer w/Filter Cap, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogeni Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating Luers, Sterile
The blood tubing accessory with CLAVE Connector Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave, Removable 2 Gang (Blue, Yellow) 1o2 Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device i Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave, Rotating Luer w/Filter Cap, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogeni Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer w/Filter Cap, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended f Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device in Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-p Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single us Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave, Luer Lock, Sterile
The blood tubing accessory with CLAVE Connector is Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, ste Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a singl Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2 Valve, 2 Clave, Pre-Pierced Port, Luer Lock, Sterile
The blood tubing accessory with C Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a sing Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, no Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, steril Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, ste Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, ste Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave, 2 Ext, Rotating Luer, Sterile
The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic devi Terminated |
FMG | None listed |
| Jul 31, 2017 | ICU Medical, Inc. 120" (305 cm) 10 Drop Primary Set w/2 MicroClave, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile
The blood tubing accessory with CLAVE Connector is a single use, st Terminated |
FMG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.