Brand Name | EKOSONIC ENDOVASCULAR CATHETER |
Type of Device | EKOSONIC ENDOVASCULAR CATHETER |
Manufacturer (Section D) |
EKOS CORPORATION |
11911 north creek parkway s |
bothell, wa |
|
Manufacturer (Section G) |
EKOS CORPORATION |
11911 north creek parkway |
|
bothell, wa |
|
Manufacturer Contact |
sandra
bausback-aballo
|
300 conshohocken state rd, |
300 four falls corporate ctr. |
west conshohocken, pa
|
3311537
|
|
MDR Report Key | 9989392 |
MDR Text Key | 188680681 |
Report Number | 3001627457-2020-00012 |
Device Sequence Number | 1 |
Product Code |
KRA
|
UDI-Device Identifier | 00858593006189 |
UDI-Public | 00858593006189 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K182324 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/13/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2021 |
Device Model Number | 500-55150 |
Device Catalogue Number | 500-55150 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/25/2020 |
Initial Date Manufacturer Received |
04/13/2020 |
Initial Date FDA Received | 04/23/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/28/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |