Catalog Number

460639

Brand Name

AcQRate Dx Fixed Curve Catheter

Version/Model Number

4J Sp 100 cm 5F 5 mm

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

K201445

Product Code

DRF

Product Code Name

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Public Device Record Key

f4daa752-5a8d-4eb5-8f22-e4335627d13f

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-