Chocolate XD PTCA Balloon Catheter NHC - Chocolate XD PTCA Balloon Catheter NHC - TRIREME MEDICAL, LLC

Duns Number:623861577

Device Description: Chocolate XD PTCA Balloon Catheter NHC

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More Product Details

Catalog Number

CD141402515RX

Brand Name

Chocolate XD PTCA Balloon Catheter NHC

Version/Model Number

A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153682

Product Code Details

Product Code

LOX

Product Code Name

Catheters, Transluminal Coronary Angioplasty, Percutaneous

Device Record Status

Public Device Record Key

b6a87c7c-e4eb-4951-9e56-21f25b95f0a8

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

February 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRIREME MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 199