Vado - Steerable Sheath, Bidirectional - KALILA MEDICAL, INC.

Duns Number:015986592

Device Description: Steerable Sheath, Bidirectional

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More Product Details

Catalog Number

SS8FMB74

Brand Name

Vado

Version/Model Number

SS8FMB74

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2018

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

-

Product Code Details

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Device Record Status

Public Device Record Key

11b48a0a-61fb-4d1e-b950-b3700b3c29d6

Public Version Date

March 05, 2020

Public Version Number

5

DI Record Publish Date

May 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KALILA MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5