QuikCAS Cardiodrive Sterile Components - The Stereotaxis Cardiodrive is intended for - STEREOTAXIS, INC.

Duns Number:024942265

Device Description: The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only co

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More Product Details

Catalog Number

001-001751-1

Brand Name

QuikCAS Cardiodrive Sterile Components

Version/Model Number

1

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

K071029

Product Code Details

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

139f3e68-8462-4244-bed5-58dbd1a43390

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STEREOTAXIS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 19