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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 atherectomy systems
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Peripheral atherectomy systems - other
Peripheral atherectomy systems - other
C010402020699
14 devices
Devices
Turbo-Elite Laser Atherectomy Catheter
Spectranetics Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Turbo-Elite Laser Atherectomy Catheter
Spectranetics Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Spur
Reflow Medical, Inc.
·
,
US
Class IIa
CE/MDR
Turbo-Elite Laser Atherectomy Catheter
Spectranetics Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Turbo-Elite Laser Atherectomy Catheter
Spectranetics Corporation
·
,
US
Class IIa
CE/MDD
Turbo-Elite Laser Atherectomy Catheter
Open recall
Spectranetics Corporation
·
,
US
Class IIa
FDA 510(k)
K170059
Active
Cleared 7 Apr 2017
FDA 510(k)
K250385
Active
Cleared 13 Mar 2025
+2
authorizations
Turbo-Elite Laser Atherectomy Catheter
Spectranetics Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Turbo-Elite Laser Atherectomy Catheter
Spectranetics Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
Spur
Reflow Medical, Inc.
·
,
US
Class IIa
FDA De Novo
DEN240048
Active
Cleared 29 May 2025
CE/MDR
+1
authorizations
Turbo-Elite Laser Atherectomy Catheter
Spectranetics Corporation
·
,
US
Class IIa
CE/MDD
GUDID
on market
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