ClearanceBrief
510(k) K101274 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories

VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM

ApplicantMaquet Cardiovascular, LLC, San Jose CA, US
DecisionSubstantially Equivalent, Jun 11, 2010
ReceivedMay 6, 2010
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K101274

DateFirm and productCodeLinked 510(k)
Jul 15, 2026Maquet Cardiovascular, LLC
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K10127
Open, Classified		 GEINone listed
Apr 18, 2025Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope,
Open, Classified		 GEINone listed
Apr 16, 2025Maquet Cardiovascular, LLC
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2).
Open, Classified		 GEINone listed
Jan 3, 2025Maquet Cardiovascular, LLC
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Open, Classified		 GEINone listed
Jan 3, 2025Maquet Cardiovascular, LLC
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Open, Classified		 GEINone listed
Jul 11, 2024Maquet Cardiovascular, LLC
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,
Open, Classified		 GEINone listed
Jun 24, 2024Maquet Cardiovascular, LLC
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The
Open, Classified		 GEINone listed
Apr 4, 2023Maquet Cardiovascular, LLC
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000
Open, Classified		 GEINone listed
Jan 19, 2023Maquet Cardiovascular, LLC
Hemopro 2 with Vasoshield, Model VH-4001
Open, Classified		 GEINone listed
Dec 6, 2013Maquet Cardiovascular, LLC
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harves
Terminated		 GEINone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.