Identity
- Trade Name
- Pronto® XL extraction catheter FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- The 14F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system and to infuse/deliver diagnostic or therapeutic agents. FDA UDI
- Model / Reference
- 5090 FDA UDI
- Description
- The 14F PRONTO XL extraction catheters are indicated for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, the removal/aspiration of embolic material (thrombus/debris) from vessels of the deep venous system and to infuse/deliver diagnostic or therapeutic agents. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20650900 FDA UDI
- 510(k) Number
- K112571 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Catheter Gauge — 14 French FDA UDI
Pronto® XL extraction catheter by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA UDI 377de595-71db-4c17-a2b4-bc29f4e9ae2f 37 fields · synced Jun 1, 2026