Duns Number:097664937
Device Description: The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aorti The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
Catalog Number
-
Brand Name
Ultra IABP Catheter Kit
Version/Model Number
IMU7F-35
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"
Yes
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
K082746,K082746,K082746
Product Code
DSP
Product Code Name
System, Balloon, Intra-Aortic And Control
Public Device Record Key
6549282c-5bd3-4e86-8e5d-a441729e60ba
Public Version Date
July 20, 2020
Public Version Number
6
DI Record Publish Date
July 20, 2015
Package DI Number
00837654076415
Quantity per Package
5
Contains DI Package
00850012832515
Package Discontinue Date
July 14, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |