Pronto® LP extraction catheter - The Pronto LP catheter is indicated for the - Vascular Solutions, Inc.

Duns Number:008999906

Device Description: The Pronto LP catheter is indicated for the removal of fresh, soft emboli and thrombi from The Pronto LP catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Pronto® LP extraction catheter

Version/Model Number

5015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Device Record Status

Public Device Record Key

a2ec7ee7-a767-4ed2-bd1b-6a73474b0d8d

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

September 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VASCULAR SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 238
U Unclassified 12