Atrieve™ Vascular Snare Kit - Atrieve™ Vascular Snare Kit 6F - ARGON MEDICAL DEVICES, INC.

Duns Number:140727624

Device Description: Atrieve™ Vascular Snare Kit 6F

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More Product Details

Catalog Number

382006015

Brand Name

Atrieve™ Vascular Snare Kit

Version/Model Number

382006015

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"

Yes

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

K021606

Product Code Details

Product Code

MMX

Product Code Name

Device, Percutaneous Retrieval

Device Record Status

Public Device Record Key

6a6c1a7a-9a75-407e-b061-6906d14c6003

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

September 20, 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