Spectre™ Guidewire - The Spectre guidewire is intended for use in - Vascular Solutions, Inc.

Duns Number:008999906

Device Description: The Spectre guidewire is intended for use in percutaneous procedures to introduce and posi The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

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More Product Details

Catalog Number

-

Brand Name

Spectre™ Guidewire

Version/Model Number

7386

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

ddc290ad-c4ec-4378-939b-0704f057d055

Public Version Date

November 11, 2019

Public Version Number

4

DI Record Publish Date

January 10, 2017

Additional Identifiers

Package DI Number

M20673861

Quantity per Package

5

Contains DI Package

M20673860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"VASCULAR SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 238
U Unclassified 12