FDA.reportPublic FDA data

SAPHENA MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30111717763011171776SAPHENA MEDICAL1N2020-04-25375 West St West Bridgewater MA US 02379

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M718VPX4000Venapax - The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneall or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external tothe parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.949-285-3517cblake@saphenamedical.com
M718VPX4000Venapax - The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneall or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external tothe parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.904-741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1748311004879789K140603ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETMGEI2014-07-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI12014-07-31

PMN#

GUDID#

Venapax - The Saphena Medical OnePass Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extra peritoneall or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external tothe parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.

SAPHENA MEDICAL, INC.

2024-06-06