Search Results
Found 1 results
510(k) Data Aggregation
(30 days)
FMD Peripheral Guidewires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral use only.
The FMD Peripheral Guide Wire F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The FMD Peripheral Guide Wire F-14 and F-18 in this submission are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190 cm to 300 cm. The FMD Peripheral Guide Wire F-14 and F-18 with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The basic structure of the FMD Peripheral Guide Wire F-14 and F-18 consists of a stainless steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion of the guide wire is coated with PTFE coating, and the distal portion is coated with a hydrophilic coating. The FMD Peripheral Guide Wire F-18 DP 25 is available with a pre-shaped tip configuration. All other models are available in straight tip configuration.
N/A
Ask a specific question about this device
Page 1 of 1