Cleaner15™ Rotational Thrombectomy System - Cleaner15™ Rotational Thrombectomy System 7F x - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Cleaner15™ Rotational Thrombectomy System 7F x 135cm

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More Product Details

Catalog Number

700115

Brand Name

Cleaner15™ Rotational Thrombectomy System

Version/Model Number

700115

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

-

Product Code Details

Product Code

KRA

Product Code Name

Catheter, Continuous Flush

Device Record Status

Public Device Record Key

22376f7f-6a93-472c-81fd-54d5ab457fc6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARGON MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 347
2 A medical device with a moderate to high risk that requires special controls. 1205