Catalog Number

503658X

Brand Name

SV WIRE

Version/Model Number

503658X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K930091,K930091

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

e4c74f35-da4e-4cea-8b44-7ac337bec43d

Public Version Date

February 15, 2022

Public Version Number

2

DI Record Publish Date

January 26, 2021

Package DI Number

20705032056080

Quantity per Package

5

Contains DI Package

10705032056083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX