RX TAKERU - RX TAKERU is a Percutaneous Transluminal Coronary - KANEKA CORPORATION

Duns Number:690535406

Device Description: RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Ca RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).

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More Product Details

Catalog Number

DC-RY3520UA2

Brand Name

RX TAKERU

Version/Model Number

DC-RY3520UA2

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

K163372

Product Code Details

Product Code

LOX

Product Code Name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device Record Status

Public Device Record Key

2e581ba3-417d-4ec8-a9a7-339052230b78

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

June 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KANEKA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1041
U Unclassified 1