Atlas FDA

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)

FDA 510(k) clearance K251238 · decided 2025-05-30

Clearance details

K-number
K251238
Device name
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
Applicant
Maquet Cardiovascular, LLC
Decision
Substantially Equivalent
Date received
2025-04-22
Decision date
2025-05-30
Days to decision
38 days
Clearance type
Traditional
Product code
GEI
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Wayne, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW H recall (Z-2636-2025)Maquet Cardiovascular, LLC2025-09-25

PMA approvals by this applicant

RecordFirmDate
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM (P840029/S007)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD ETS(TM) FLANGED GRAFT (P840029/S004)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM (P840029/S006)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT (P840029/S014)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR (P840029/S011)Maquet Cardiovascular, LLC1993-05-17
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S010)Maquet Cardiovascular, LLC1993-05-11
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S009)Maquet Cardiovascular, LLC1993-05-11
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S005)Maquet Cardiovascular, LLC1993-05-11