Atlas FDA

PRIMARY IV SET

FDA 510(k) clearance K964435 · decided 1997-04-02

Clearance details

K-number
K964435
Device name
PRIMARY IV SET
Applicant
Icu Medical, Inc.
Decision
Substantially Equivalent
Date received
1996-11-05
Decision date
1997-04-02
Days to decision
148 days
Clearance type
Traditional
Product code
FMG
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
San Clemente, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Loc recall (Z-0154-2026)ICU Medical, Inc.2025-10-23
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set recall (Z-0106-2018)ICU Medical, Inc.2017-11-17
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rota recall (Z-2716-2017)ICU Medical, Inc.2017-06-26
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Val recall (Z-2717-2017)ICU Medical, Inc.2017-06-26
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rota recall (Z-2718-2017)ICU Medical, Inc.2017-06-26
28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rot recall (Z-2719-2017)ICU Medical, Inc.2017-06-26
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoCl recall (Z-2720-2017)ICU Medical, Inc.2017-06-26
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear. Product Usage: The device is a single use, s recall (Z-2721-2017)ICU Medical, Inc.2017-06-26
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings recall (Z-2722-2017)ICU Medical, Inc.2017-06-26
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. Prod recall (Z-2723-2017)ICU Medical, Inc.2017-06-26
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings recall (Z-2724-2017)ICU Medical, Inc.2017-06-26
133" 60 Drop 24 Hour Primary Set w/2 Bravo24, 2 Gang 1o2 Manifold, Rotating Luer, 1 Ext, I recall (Z-0980-2017)ICU Medical, Inc.2017-01-10
119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroC recall (Z-1588-2015)ICU Medical, Inc.2015-05-07
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non- recall (Z-1589-2015)ICU Medical, Inc.2015-05-07
104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/ recall (Z-1590-2015)ICU Medical, Inc.2015-05-07
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallb recall (Z-1591-2015)ICU Medical, Inc.2015-05-07
108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp recall (Z-1592-2015)ICU Medical, Inc.2015-05-07
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, recall (Z-1593-2015)ICU Medical, Inc.2015-05-07
98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifus recall (Z-1594-2015)ICU Medical, Inc.2015-05-07
98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tu recall (Z-1595-2015)ICU Medical, Inc.2015-05-07
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 F recall (Z-2619-2014)ICU Medical, Inc.2014-09-19
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 F recall (Z-2620-2014)ICU Medical, Inc.2014-09-19
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, recall (Z-2621-2014)ICU Medical, Inc.2014-09-19
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Ro recall (Z-2622-2014)ICU Medical, Inc.2014-09-19
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non recall (Z-2130-2012)ICU Medical, Inc.2012-08-02