Duns Number:080338871
Device Description: The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percu The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneous use.The Houdini Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Catalog Number
-
Brand Name
Cruzar Medsystems Inc.
Version/Model Number
CM-3500
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 16, 2019
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
-
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
4e182c85-923f-4655-bb25-6473b9ef270c
Public Version Date
December 22, 2021
Public Version Number
8
DI Record Publish Date
August 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |