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Cardiocirculatory system devices
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Arterio-venous system devices
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Angiography and haemodynamic devices
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Peripheral angiography devices
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Peripheral angiography therapeutic devices
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Peripheral vascular system total chronic occlusion devices
Peripheral vascular system total chronic occlusion devices
C0104020209
15 devices
Devices
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
IMPEDE-FX Embolization Plug
Shape Memory Medical Inc
·
,
US
Class IIb
CE/MDR
1000156813
Active
Valid to Dec 2030
CE/MDR
1000275865
Active
Valid to Dec 2030
+2
authorizations
IMPEDE-FX Embolization Plug
Shape Memory Medical Inc
·
,
US
Class IIb
CE/MDR
FDA 510(k)
K182390
Active
Cleared 23 May 2019
+2
authorizations
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Santreva-ATK
AngioSafe, Inc.
·
,
US
Class IIa
FDA 510(k)
K252315
Active
Cleared 22 Sep 2025
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
IMPEDE-FX RapidFill
Shape Memory Medical Inc
·
,
US
Class IIb
CE/MDR
1000275865
Active
Valid to Dec 2030
CE/MDR
1000156813
Active
Valid to Dec 2030
+1
authorizations
Wingman
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
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