Atlas FDA

VASOVIEW HemoPro Endoscopic Vessel Harvesting System

FDA 510(k) clearance K153194 · decided 2016-04-19

Clearance details

K-number
K153194
Device name
VASOVIEW HemoPro Endoscopic Vessel Harvesting System
Applicant
Maquet Cardiovascular, LLC
Decision
Substantially Equivalent
Date received
2015-11-04
Decision date
2016-04-19
Days to decision
167 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 Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 recall (Z-0092-2025)Maquet Cardiovascular, LLC2024-10-25
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjuncti recall (Z-2337-2024)Maquet Cardiovascular, LLC2024-07-11
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunct recall (Z-2176-2024)Maquet Cardiovascular, LLC2024-06-24
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. recall (Z-0724-2024)Maquet Cardiovascular, LLC2024-01-12
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 recall (Z-1335-2023)Maquet Cardiovascular, LLC2023-04-04
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W recall (Z-1337-2023)Maquet Cardiovascular, LLC2023-04-04

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