Atlas FDA

CLAVE CONNECTOR

FDA 510(k) clearance K970855 · decided 1997-06-24

Clearance details

K-number
K970855
Device name
CLAVE CONNECTOR
Applicant
Icu Medical, Inc.
Decision
Substantially Equivalent
Date received
1997-03-10
Decision date
1997-06-24
Days to decision
106 days
Clearance type
Traditional
Product code
FPA
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
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z376 recall (Z-0658-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, P recall (Z-0659-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave, 3 Clamps, Rotating Luer, recall (Z-0660-2014)ICU Medical, Inc.2014-01-09
183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave (Yellow, Green Rings), 4 Anti-Syphon recall (Z-0661-2014)ICU Medical, Inc.2014-01-09
184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave, 2 Anti-Syphon Valves, 0.2 Micron Posi recall (Z-0662-2014)ICU Medical, Inc.2014-01-09
31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave, Orange Ring, 2 Anti Syphon Valves, 0.2 recall (Z-0663-2014)ICU Medical, Inc.2014-01-09
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a s recall (Z-0664-2014)ICU Medical, Inc.2014-01-09
17 cm (7'') Ext Set w/NanoClave, 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, Part No. recall (Z-0665-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector, Rotating Luer, P recall (Z-0666-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating recall (Z-0667-2014)ICU Medical, Inc.2014-01-09
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE Clear, NanoClave T-Connector, recall (Z-0668-2014)ICU Medical, Inc.2014-01-09
8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE Clear, 0.2 Micron Filter, NanoClav recall (Z-0669-2014)ICU Medical, Inc.2014-01-09
78" Ext Set w/Check Valve, CLAVE Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave, NanoClave recall (Z-0670-2014)ICU Medical, Inc.2014-01-09
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Par recall (Z-0671-2014)ICU Medical, Inc.2014-01-09
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Par recall (Z-0672-2014)ICU Medical, Inc.2014-01-09
8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, It recall (Z-0673-2014)ICU Medical, Inc.2014-01-09
10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, I recall (Z-0674-2014)ICU Medical, Inc.2014-01-09
87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave, 0.2 Micron Filter, 4 Clam recall (Z-0675-2014)ICU Medical, Inc.2014-01-09
13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave, Rotating Luer, Par recall (Z-0676-2014)ICU Medical, Inc.2014-01-09
14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, 2 Clamps, Rota recall (Z-0677-2014)ICU Medical, Inc.2014-01-09
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check recall (Z-0678-2014)ICU Medical, Inc.2014-01-09
8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The recall (Z-0679-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, recall (Z-0680-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Par recall (Z-0681-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotating recall (Z-0682-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave Clear, NThe ICU Needleless Connect recall (Z-0683-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave" T-Connector recall (Z-0684-2014)ICU Medical, Inc.2014-01-09
10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave Clear, Tri- Connector, NanoClave" recall (Z-0685-2014)ICU Medical, Inc.2014-01-09
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon recall (Z-0686-2014)ICU Medical, Inc.2014-01-09
78" Ext Set w/2 BCV-Clave, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, recall (Z-0687-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, recall (Z-0688-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Par recall (Z-0689-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Pa recall (Z-0690-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. recall (Z-0691-2014)ICU Medical, Inc.2014-01-09
10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave", Clamp, Rotatin recall (Z-0692-2014)ICU Medical, Inc.2014-01-09
10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave Clear, NanoClave", Clamp, Lu recall (Z-0693-2014)ICU Medical, Inc.2014-01-09
7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1 recall (Z-0694-2014)ICU Medical, Inc.2014-01-09
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Par recall (Z-0695-2014)ICU Medical, Inc.2014-01-09
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave Clear (Yello recall (Z-0696-2014)ICU Medical, Inc.2014-01-09
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Par recall (Z-0697-2014)ICU Medical, Inc.2014-01-09
30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, NanoCl recall (Z-0698-2014)ICU Medical, Inc.2014-01-09
120" 10 Drop Primary Set w/2 BCV-CLAVE, Remv 2 Gang CLAVE Stopcock, Remv CLAVE Stopcock, N recall (Z-0699-2014)ICU Medical, Inc.2014-01-09
5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1 recall (Z-0700-2014)ICU Medical, Inc.2014-01-09
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot recall (Z-0701-2014)ICU Medical, Inc.2014-01-09
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 279 recall (Z-0702-2014)ICU Medical, Inc.2014-01-09
5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # recall (Z-0703-2014)ICU Medical, Inc.2014-01-09
28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave T-Connector, Cl recall (Z-0704-2014)ICU Medical, Inc.2014-01-09
6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroCla recall (Z-0705-2014)ICU Medical, Inc.2014-01-09
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE Clear, Clamp, NanoClave T-Connecto recall (Z-0706-2014)ICU Medical, Inc.2014-01-09
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue, Lavender Rings), 3 Anti-S recall (Z-0707-2014)ICU Medical, Inc.2014-01-09