Z-MED Percutaneous Transluminal Valvuloplasty Catheter

B BRAUN INTERVENTIONAL SYSTEMS, INC

Balloon aortic valvuloplasty

Non-clinical testing has demonstrated that NuMED’s Balloon Catheter Systems are MR Conditional. The following labeling is specific to NuMED’s catheters and does not apply to guidewires or other accessories used in combination with NuMED’s Balloon Catheter Systems. Users should consult the instructions for use and MRI safety information of other accessory devices used with NuMED’s catheters. NuMED’s Balloon Catheter Systems may be safely scanned anywhere in the body at 1.5T or 3.0T under the following conditions. Failure to follow these conditions may result in injury.