Search Results

For use with Medrad Mark II, III,and IV Angiographic Injectors.

The Coeur syringe is a six piece device (plunger jacket, barrel, retainer, dust cap, fill tube) which is used in conjunction with power injectors to inject diagnostic fluids associated with angiographic procedures. In particular, the plunger jacket acts as the seal when the plunger is moved to aspirate or inject the contrast media solution. This premarket notification describes the modification to the Coeur syringe, which is a material change to the plunger jacket. The new material Coeur intends to use for the plunger jacket is chlorobutyl.

The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Iniector Ram during the injection of contrast media into the vascular system for diagnostic purposes.

The Coeur Front Load Retrofit Kit consists of two accessory pieces for use with Medrad MCT and MCT Plus Injector Systems and older models of Medrad injectors upgraded by Medrad to resemble the MCT and MCT Plus. The kit contains a face plate and ram tip extension that allow easy use of the Coeur 200 mL Front Load Syringe on the modified versions of Medrad injectors. This premarket notification describes the Coeur Face Plate Retrofit Kit, which is a modification of the Coeur Front Load Injector Turret, which allows use of the Coeur 200 mL Front Load Syringe on older models of Medrad injectors. The Face Plate uses a standard bayonet mount to attach directly onto the Medrad injectorbase on the MCT and MCT Plus injectors. The ram tip extension is then attached to the existing ram tip and tightened into place to prevent slippage. Once in place, the Coeur 200 mL Front Load Syringe may be used easily on the injectors.