Address:Ceintuurbaan Noord 150,Roden Groningen,NL
Device Description : The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or p The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014” Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014”/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen.To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the NHancer Rx are coated with MDX (silicone) coating.To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen
Device Class : 2
Duns Number: 489997508
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TrapIt Trapping Balloon Catheters have an integrated shaft system and a ball The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.
Device Class : 2
Duns Number: 489997508
Premarket Exempt : No
Prescription Use : Yes
Device Description : The TrapIt Trapping Balloon Catheters have an integrated shaft system and a ball The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.
Device Class : 2
Duns Number: 489997508
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ReCross is a dual lumen catheter intended to use in the coronary and/or peri The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014” Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port.To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the ReCross are coated with MDX (silicone) coating.To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen
Device Class : 2
Duns Number: 489997508
Premarket Exempt : No
Prescription Use : Yes