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Pronto® .035" extraction catheter

FDA UDI

Class II (US FDA UDI)

by Vascular Solutions, Inc.

Identity

Trade Name
Pronto® .035" extraction catheter FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Device Name
The Pronto .035” is 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
5040 FDA UDI
Description
The Pronto .035” is 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
M20650400 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 — 10 French FDA UDI

Pronto® .035" 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

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Manufacturer

Manufacturer
Vascular Solutions, Inc.

Sources (1)

  • FDA UDI d433613a-9350-43cf-9cd7-200449ba1791 36 fields · synced May 30, 2026