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Device Recall Wingman 35 Crossing Catheter
Model / Serial
Lot Numbers Model number: WGM35065US 1508074, 1509154R, 1510204, 1510054R, 1602164,1604194R,1605133, 1606273R2, 1701244. Model number: WGM35090US 1502053, 1505144,1508264R, 1508265,1601044,1603024,1603214, 1605193, 1606304, 1610314. Model number: WGM35135US 1503094, 1505061, 1506104, 1508204R, 1508205, 1510074R, 1511304, 1512174,1512174R, 1602174, 1604213, 1604253, 1605113, 1606203, 1611034. Model No. WGM35065CE 1508074R, 150874R1, 1509154, 1510024, 1510024R, 1510054, 1602164R, 1604194, 1606273, 1606273R. Model No. WGM35090CE 1502053R, 1505144R, 1505144R1, 1505144R2, 1505144R3, 1508264, 1601044R, 1603024R, 1603024R2, 1603214R, 1603214R2, 1605194, 1605194R, 1605194R2. Model No. WGM35135CE 1503094R, 1503094R1, 1503094R2, 1505061R, 1505264, 1506104R, 1508204, 1508205R, 1510074, 1602174R, 1604213R, 1606203R, 1606203R2, 1606204, 1606204R, 1611114.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide in the states of : NJ, FL, CA, GA, MI, OH and countries of: Germany, Turkey, and AU.
Product Description
Wingman 35 Crossing Catheter, 65cm, || Model Numbers: || WGM35065US || WGM35065CE || WGM35090US || WGM35090CE || WGM35135US || WGM35135CE
Manufacturer
ReFlow Medical
1 Event
Recall of Device Recall Wingman 35 Crossing Catheter
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Manufacturer
ReFlow Medical
Manufacturer Address
ReFlow Medical, 1003 Calle Sombra, San Clemente CA 92673-6244
Manufacturer Parent Company (2017)
Reflow Medical Inc.
Source
USFDA
Language
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