Identity
- Trade Name
- Micro Rx FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- RX135 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- RX135 FDA UDI
- Primary DI / UDI-DI
- 08718481740354 FDA UDI
- 510(k) Number
- K223728 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
Micro Rx 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 9b6a777d-3bca-46b9-b51c-0d661cee89f6 35 fields · synced May 31, 2026