ShapeIT SI014135

GUDID 08718481740361

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.

IMDS Operations B.V.

Vascular guide-catheter, single-use

• Primary Device ID: 08718481740361
• NIH Device Record Key: 86322e6e-c83e-4819-a6b6-0e88484d3b83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ShapeIT
• Version Model Number: SI014135
• Catalog Number: SI014135
• Company DUNS: 489997508
• Company Name: IMDS Operations B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08718481740361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241611

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-18
• Device Publish Date: 2025-08-08

Devices Manufactured by IMDS Operations B.V.

• 08718481740361 - ShapeIT: 2025-08-18The 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.
• 08718481740361 - ShapeIT: 2025-08-18 The ShapeIT is a rapid exchange single lumen guide wire support catheter. The ShapeIT consists of a distal shaft connected to a
• 08718481740354 - Micro Rx: 2023-12-27 The Micro Rx is a guide wire support catheter with hydrophilic coating intended to support a guide wire during access of coronar
• 08718481740231 - NHancer Rx: 2022-09-09 The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0
• 08718481740262 - TrapIT: 2022-09-09 The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen w
• 08718481740279 - TrapIT: 2022-09-09 The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen w
• 08718481740309 - ReCross: 2022-09-09 The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014” Ov