Secondi™ Support Catheter - The Secondi™ Support Catheter is a dual lumen - Thermopeutix, Inc.

Duns Number:138648154

Device Description: The Secondi™ Support Catheter is a dual lumen catheter with an integrated spine wire and t The Secondi™ Support Catheter is a dual lumen catheter with an integrated spine wire and two guidewire lumens designed for use in the peripheral vasculature. The catheter provides support for guidewires during interventional procedures and allows for the exchange of one proximally located guidewire for another while maintaining access to the distal vasculature over a second distal guidewire. The Secondi™ Support Catheter has a hydrophilic coating on the distal portion of the catheter, and is compatible with various guidewire diameters and lengths. The catheter has a single radiopaque marker band located at the distal tip of each of the catheter’s guide wire lumens.

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More Product Details

Catalog Number

-

Brand Name

Secondi™ Support Catheter

Version/Model Number

S14/18-60-150

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

K130850

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

22499f99-bbf4-4c1e-b696-5b014cb29841

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERMOPEUTIX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 65