Gliderflex PTA Balloon Catheter - TRIREME MEDICAL, LLC

Duns Number:623861577

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More Product Details

Catalog Number

-

Brand Name

Gliderflex PTA Balloon Catheter

Version/Model Number

B

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

K101062

Product Code Details

Product Code

LIT

Product Code Name

Catheter, Angioplasty, Peripheral, Transluminal

Device Record Status

Public Device Record Key

ae58197d-99b9-4ac3-93e2-0e0c7796cb90

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

February 13, 2017

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