Duns Number:482661753
Device Description: CERENOVUS Aspiration Tubing Set ID: 0.110 in / 2.79 mm Working length: 112 in / 284 cm
Catalog Number
EVT110
Brand Name
CERENOVUS
Version/Model Number
EVT110
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
K193380
Product Code
NRY
Product Code Name
CATHETER, THROMBUS RETRIEVER
Public Device Record Key
2150619b-ee28-40bc-98b7-39c47b763012
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
May 14, 2021
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |