Turbo Elite™ - Turbo-Elite™ Laser Atherectomy Catheter - Spectranetics Corporation

Duns Number:151047370

Device Description: Turbo-Elite™ Laser Atherectomy Catheter

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More Product Details

Catalog Number

425-135-01

Brand Name

Turbo Elite™

Version/Model Number

425-135-01AA

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)

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

MCW

Product Code Name

Catheter, Peripheral, Atherectomy

Device Record Status

Public Device Record Key

aefe7163-a339-4487-bc50-e15994d5d36a

Public Version Date

October 26, 2021

Public Version Number

3

DI Record Publish Date

February 06, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPECTRANETICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 251
3 A medical device with high risk that requires premarket approval 126