Duns Number:008999906
Device Description: The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires i The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use during two guidewire procedures. The Twin-Pass .023” catheters are also used to sub selectively infuse/deliver diagnostic or therapeutic agents and to measure intra-arterial pressure within the peripheral vasculature.
Catalog Number
-
Brand Name
Twin-Pass® 023" dual access catheter
Version/Model Number
5230
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 04, 2019
Issuing Agency
In HIBCC
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
K062877
Product Code
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
114cd43e-f55b-4c79-8865-8087072f0632
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 05, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |