Simon Nitinol Filter™ - Simon Nitinol Filter™ Antecubital Filter Set - Bard Peripheral Vascular, Inc.

Duns Number:135057938

Device Description: Simon Nitinol Filter™ Antecubital Filter Set

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More Product Details

Catalog Number

2320A

Brand Name

Simon Nitinol Filter™

Version/Model Number

2320A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K970099

Product Code Details

Product Code

DTK

Product Code Name

FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Record Status

Public Device Record Key

12ba7428-e008-46a4-8d22-0f0b36b7e943

Public Version Date

November 02, 2020

Public Version Number

3

DI Record Publish Date

October 02, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BARD PERIPHERAL VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 2835
3 A medical device with high risk that requires premarket approval 190