CVX-300®-P - Excimer Laser System - Spectranetics Corporation

Duns Number:151047370

Device Description: Excimer Laser System

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

CVX300P

Brand Name

CVX-300®-P

Version/Model Number

CVX300P

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

-

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

LPC

Product Code Name

Device, Angioplasty, Laser, Coronary

Device Record Status

Public Device Record Key

ba5f4c05-6086-4a13-9c9f-7efd5a6ccdc3

Public Version Date

October 26, 2021

Public Version Number

5

DI Record Publish Date

August 26, 2014

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