Cardioblate® CryoFlex™ - ACCY 65TC1 CRYOFLEX TANK CARRIER EN - MEDTRONIC, INC.

Duns Number:006261481

Device Description: ACCY 65TC1 CRYOFLEX TANK CARRIER EN

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More Product Details

Catalog Number

-

Brand Name

Cardioblate® CryoFlex™

Version/Model Number

65TC1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 05, 2018

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K053436

Product Code Details

Product Code

OCL

Product Code Name

Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Device Record Status

Public Device Record Key

d0a4e234-bb9f-488a-9242-66d1f22607e8

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601