Atlas FDA

SNIPER ELITE MODEL-OR-E3872XX SERIES

FDA 510(k) clearance K011905 · decided 2001-08-28

Clearance details

K-number
K011905
Device name
SNIPER ELITE MODEL-OR-E3872XX SERIES
Applicant
Maxxim Medical
Decision
Substantially Equivalent
Date received
2001-06-19
Decision date
2001-08-28
Days to decision
70 days
Clearance type
Special
Product code
DQX
Device class
2
Regulation number
870.1330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Athens, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3 recall (Z-0623-2010)Cordis Corporation2010-01-13
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301, .03 recall (Z-1267-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087302, .03 recall (Z-1268-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087303, .03 recall (Z-1269-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087304, .03 recall (Z-1270-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087305, .03 recall (Z-1271-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087306, .03 recall (Z-1272-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308, .03 recall (Z-1273-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087309, .03 recall (Z-1274-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087311, .03 recall (Z-1275-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087312, .03 recall (Z-1276-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087313, .03 recall (Z-1277-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087314, .03 recall (Z-1278-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087315, .03 recall (Z-1279-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316, .03 recall (Z-1280-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087317, .03 recall (Z-1281-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087326, .03 recall (Z-1282-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387301, .03 recall (Z-1283-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387302, .03 recall (Z-1284-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387303, .03 recall (Z-1285-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387304, .03 recall (Z-1286-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387305, .03 recall (Z-1287-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387306, .03 recall (Z-1288-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387307, .03 recall (Z-1289-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387308, .03 recall (Z-1290-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387309, .03 recall (Z-1291-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387310, .03 recall (Z-1292-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387311, .03 recall (Z-1293-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387312, .03 recall (Z-1294-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387313, .03 recall (Z-1295-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387314, .03 recall (Z-1296-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387316, .03 recall (Z-1297-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387318, .03 recall (Z-1298-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387319, .03 recall (Z-1299-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387320, .03 recall (Z-1300-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387321, .03 recall (Z-1301-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387322, .03 recall (Z-1302-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323, .03 recall (Z-1303-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387325, .03 recall (Z-1304-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387326, .03 recall (Z-1305-2009)Argon Medical Devices, Inc2009-05-26
Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold recall (Z-1306-2009)Argon Medical Devices, Inc2009-05-26
Hydrophilic Guidewire, Catalog Number: VM18352, .035/150 cm, regular/angled/standard, sold recall (Z-1307-2009)Argon Medical Devices, Inc2009-05-26
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0882-2008)Argon Medical Devices, Inc2008-01-31
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0883-2008)Argon Medical Devices, Inc2008-01-31
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0884-2008)Argon Medical Devices, Inc2008-01-31
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0885-2008)Argon Medical Devices, Inc2008-01-31
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0886-2008)Argon Medical Devices, Inc2008-01-31
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0887-2008)Argon Medical Devices, Inc2008-01-31
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0888-2008)Argon Medical Devices, Inc2008-01-31
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-A recall (Z-0889-2008)Argon Medical Devices, Inc2008-01-31