It should be noted that any device orginally approved through the PMA process may have later been modified and the new modified device may have been approved under via the 510k approval pathway. To determine if any given clients device is one approved under the 510k process vs the PMA process it will be necessary to determine the manufacture, brand and model of the device implanted.
|B BRAUN VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER 510k.pdf|
|BOSTON SCIENTIFIC CORP STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM 510k.pdf|
|BOSTON SCIENTIFIC CORP. STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM 510k.pdf|
|CORDIS CORP TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B 510k.pdf|
|CORDIS CORPORATION CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F 510k.pdf|
|CR Bard Inc G2 EXPRESS FILTER SYSTEM-FEMORAL RF400F AND JUGULAR SUBCLAVIAN RF400J DELIVERY KITS 510k.pdf|