Catalog Number

9-TV45X45-12F-080

Brand Name

Amplatzer™ TorqVue™ 45° x 45°

Version/Model Number

Delivery Sheath

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

K163000

Product Code

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

d5752b96-d1c6-4adc-bd3f-6d0e2912f26c

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

February 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-