Duns Number:008999906
Device Description: The Minnie support catheters are intended to be used in conjunction with steerable guidewi The Minnie support catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the arterial and/or coronary vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices. The Minnie support catheters also may be used to subselectively infuse/deliver therapeutic agents.
Catalog Number
-
Brand Name
Minnie® support catheter
Version/Model Number
5711
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
76702029-d932-4930-b969-816873186dd1
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
M20657111
Quantity per Package
5
Contains DI Package
M20657110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |