Duns Number:070156955
Catalog Number
14111-2571-000
Brand Name
THORATEC® PVAD™, VENTRICULAR CANNULA - LONG, STRAIGHT, BEVELED TIP WITH SIDE HOL
Version/Model Number
14111-2571-000
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
-
Product Code
DSQ
Product Code Name
Ventricular (Assisst) Bypass
Public Device Record Key
9592b177-208d-47c3-9171-abc4d269c4c0
Public Version Date
February 05, 2021
Public Version Number
7
DI Record Publish Date
September 20, 2014
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 156 |