ALN Pre-Curved RS - The device is a Pre-curved Extraction Kit of ALN - A.L.N.

Duns Number:272983094

Device Description: The device is a Pre-curved Extraction Kit of ALN Vena Cava Filter including a puncture nee The device is a Pre-curved Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.

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More Product Details

Catalog Number

-

Brand Name

ALN Pre-Curved RS

Version/Model Number

FT.902010/VS2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K163699

Product Code Details

Product Code

DTK

Product Code Name

Filter, Intravascular, Cardiovascular

Device Record Status

Public Device Record Key

b50b6010-7d79-475c-ac46-633f1bc073cf

Public Version Date

November 26, 2018

Public Version Number

1

DI Record Publish Date

October 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"A.L.N." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9