ShapeIT (SI014135)
Imds Operations B.V.
IMDS Operations B.V.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007740583 | 3007740583 | IMDS Operations B.V. | 1 | N | 2026-01-01 | Ceintuurbaan Noord 150 Roden Groningen NL 9301 NZ |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 106227 | 1475481467 | K242337 | FlowGuide (FG60F); GuidionShort (GS60F) | DQY | 2025-04-17 |
| 106227 | 1975036887 | K241611 | ShapeIT (SI014135) | DQY | 2024-09-03 |
| 106227 | 1909906176 | K223728 | Micro Rx | DQY | 2023-07-13 |
| 106227 | 1386404737 | K210431 | ReCross | DQY | 2021-07-15 |
| 106227 | 1453797521 | K200324 | NHancer Rx | DQY | 2020-08-06 |
| 106227 | 1164713052 | K191229 | TrapIt | DQY | 2020-01-21 |
| 106227 | 1693842070 | ||||
| 106227 | 2024694430 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQY | 6 | 2025-04-17 |
PMN#
GUDID#
Guidion Short - The Guidion Short is Rapid Exchange or so-called Monorail design. The Guidion Short has a distal shaft connected to a proximal shaft / push rod with a proximal end stop connected at the proximal end. The distal shaft is stainless-steel reinforced. The reinforced distal shaft ends in an integrated soft distal tip to facilitate advancement of the device through a guiding catheter and into the main coronary vessels. In addition, the outer surface of the distal shaft and tip are equipped with a hydrophilic coating and the inner surface with a silicon coating for increased lubricity. The distal shaft has a radiopaque distal tip that in conjunction with fluoroscopy, aids in the placement of the guide extension. The distal shaft of the Guidion Short has an additional radiopaque marker at the proximal end that in conjunction with fluoroscopy, aid in preventing distal shaft exit the guiding catheter. The guide extension has two markers on the push rod that indicate approximately, the exit of the distal tip from the guiding catheter (brachial – 90 cm, femoral – 100 cm). The IMDS family of guide extensions will be used in guiding catheters of 90 and 100 cm length, supplied with accessories. The effective length of the guide extensions will be 150 cm. For Guidion Short, a flexible transition zone is present on the push rod as an additional aid for smooth entry of intravascular devices.
2026-06-01
FlowGuide - The FlowGuide is Rapid Exchange or so-called Monorail design. The FlowGuide has a distal shaft connected to a proximal shaft / push rod with a proximal end stop connected at the proximal end. The distal shaft is stainless-steel reinforced. The reinforced distal shaft ends in an integrated soft distal tip to facilitate advancement of the device through a guiding catheter and into the main coronary vessels. In addition, the outer surface of the distal shaft and tip are equipped with a hydrophilic coating and the inner surface with a silicon coating for increased lubricity. The distal shaft has a radiopaque distal tip that in conjunction with fluoroscopy, aids in the placement of the guide extension. The distal shaft of the FlowGuide has an additional radiopaque marker at the proximal end that in conjunction with fluoroscopy, aid in preventing distal shaft exit the guiding catheter. Furthermore, the FlowGuide has side holes in its distal shaft to allow blood flow through the side holes to distal vasculature to aid in reducing the risk of ischemia. The guide extension has two markers on the push rod that indicate approximately, the exit of the distal tip from the guiding catheter (brachial – 90 cm, femoral – 100 cm). The IMDS family of guide extensions will be used in guiding catheters of 90 and 100 cm length, supplied with accessories. The effective length of the guide extensions will be 150 cm. For FlowGuide, a flexible transition zone is present on the push rod as an additional aid for smooth entry of intravascular devices.
2026-06-01
ShapeIT - The ShapeIT is a rapid exchange single lumen guide wire support catheter.The ShapeIT consists of a distal shaft connected to a proximal wire shaft with a proximal end stop on the proximal end and a tip on the distal end of the catheter. On the proximal wire shaft depth markings are applied to indicate that the distal tip of the catheter is at the level of the distal tip of the guiding catheter (95 and 105 cm). Additional distal shaft transition markings are applied to indicate the distal shaft transition is reaching the distal end of the guiding catheter (110 and 120 cm).As aid in positioning the distal tip is radiopaque to make the tip visible with fluoroscopy. The distal part of the shaft is fitted with a hydrophilic coating. The inner lumen of the catheter is coated with MDX coating. The distal two centimeter can be (re)shaped, the distal end has a pre-bend of 180 degrees.
2025-08-08
Micro Rx - The Micro Rx is a guide wire support catheter with hydrophilic coating intended to support a guide wire during access of coronary and/ or peripheral vasculature. The Micro Rx consist of a distal shaft connected to a push rod with a proximal end stop on the proximal end and a tip on the distal end of the catheter. On the push rod shaft depth markings are applied to indicate that the distal tip of the catheter is at the level of the distal tip of the guiding catheter (95 and 105 cm). Additional distal shaft transition markings are applied to indicate the distal shaft transition is reaching the distal end of the guiding catheter (110 and 120 cm). As aid in positioning the distal tip is radiopaque to make the tip visible with fluoroscopy. The distal part of the shaft is fitted with a hydrophilic coating. The inner lumen of the catheter is coated with MDX coating.
2023-12-19
NHancer Rx - 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
2022-09-01
TrapIT - 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.
2022-09-01
TrapIT - 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.
2022-09-01
ReCross - 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
2022-09-01