Duns Number:002348191
Device Description: Arrow-Trerotola(TM) Over-The-Wire PTD(R) Kit (Percutaneous Thrombolytic Device)
Catalog Number
PT-12709-WC
Brand Name
ARROW
Version/Model Number
IPN035900
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
K011056,K011056
Product Code
DXE
Product Code Name
CATHETER, EMBOLECTOMY
Public Device Record Key
b723aa7a-427d-4ab5-b64b-d6f57bb14a8e
Public Version Date
May 21, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
10801902013108
Quantity per Package
1
Contains DI Package
00801902013101
Package Discontinue Date
May 15, 2019
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |