Identity
- Trade Name
- ShapeIT FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SI014135 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SI014135 FDA UDI
- Primary DI / UDI-DI
- 08718481740361 FDA UDI
- 510(k) Number
- K241611 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Vascular guide-catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular guide-catheter, single-use
ShapeIT by IMDS Operations B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IMDS Operations B.V.
Sources (1)
- FDA UDI 86322e6e-c83e-4819-a6b6-0e88484d3b83 35 fields · synced Jun 1, 2026