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Cardiocirculatory system devices
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Cardiovascular introducer sheaths
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Cardiovascular introducer sheaths, valved
Cardiovascular introducer sheaths, valved
C0502
2,149 devices
Sereny™ Hemostasis Introducer
APT Medical Inc.
·
,
China
Class IIa
CE/MDR
CN23/00002940
Active
Valid to Jun 2028
ClearSheath
Newtech Medical Devices Pvt. Ltd.
·
,
India
Class IIa
CE/MDR
Sterile Catheter Sheath Sets
Zhejiang Barty Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
DuraSheath Introducer Sheath System
Contract Medical International GmbH
·
,
Germany
Class III
CE/MDR
×2
Active
Valid to Jun 2027
GUDID
on market
Introducer Sheath Sets
BrosMed Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
Sereny™ Hemostasis Introducer
APT Medical Inc.
·
,
China
Class IIa
CE/MDR
CN23/00002940
Active
Valid to Jun 2028
Braidin™
APT Medical Inc.
·
,
China
Class III
CE/MDD
Fortress Introducer Sheath System
Open recall
Contract Medical International GmbH
·
,
Germany
Class IIa
CE/MDR
2254506CE03
Active
Valid to Jun 2027
FDA 510(k)
×2
K153197
Active
+1
authorizations
Introducer Sheath Sets
BrosMed Medical Co., Ltd.
·
,
China
Class IIa
CE/MDR
DuraSheath Introducer Sheath System
Contract Medical International GmbH
·
,
Germany
Class III
CE/MDR
×2
Active
Valid to Jun 2027
ClearSheath
Newtech Medical Devices Pvt. Ltd.
·
,
India
Class IIa
CE/MDR
Sterile Catheter Sheath Sets
Zhejiang Barty Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Sterile Catheter Sheath Sets
Zhejiang Barty Medical Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Sereny™ Hemostasis Introducer
APT Medical Inc.
·
,
China
Class IIa
CE/MDR
CN23/00002940
Active
Valid to Jun 2028
ClearSheath
Newtech Medical Devices Pvt. Ltd.
·
,
India
Class IIa
CE/MDR
DuraSheath Introducer Sheath System
Contract Medical International GmbH
·
,
Germany
Class III
CE/MDR
×2
Active
Valid to Jun 2027
F47706V
FIAB S.p.A.
·
,
Italy
Class IIa
CE/MDR
Cocoon
Vascular Innovations Co. Ltd.
·
,
Thailand
Class III
CE/MDD
Guiding Sheath
Shanghai INT Medical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
Galt VTI® Introducer Set
Galt Medical Corp.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
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