Tigertriever 13 Revascularization Device - The Tigertriever 13 device is a stentriever that - RAPID MEDICAL LTD

Duns Number:532702946

Device Description: The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol bra The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 13 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

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More Product Details

Catalog Number

TRPP7144

Brand Name

Tigertriever 13 Revascularization Device

Version/Model Number

TRPP7144

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K220808,K220808

Product Code Details

Product Code

NRY

Product Code Name

Catheter, Thrombus Retriever

Device Record Status

Public Device Record Key

0f3c3c8c-8d97-40a8-9693-ee4cfa3337d7

Public Version Date

August 05, 2022

Public Version Number

1

DI Record Publish Date

July 28, 2022

Additional Identifiers

Package DI Number

17290015107300

Quantity per Package

3

Contains DI Package

07290015107303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"RAPID MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1