Brand Name | EKOSONIC ENDOVASCULAR CATHETER |
Type of Device | EKOSONIC ENDOVASCULAR CATHETER |
Manufacturer (Section D) |
EKOS CORPORATION |
11911 north creek parkway s |
bothell WA 98011 8809 |
|
Manufacturer (Section G) |
EKOS CORPORATION |
11911 north creek parkway |
|
bothell WA 98011 8809 |
|
Manufacturer Contact |
sandara
bausback-aballo
|
300 conshohocken state rd, |
300 four falls corporate ctr. |
west conshohocken, PA 19428-2998
|
6103311537
|
|
MDR Report Key | 9079950 |
MDR Text Key | 163130101 |
Report Number | 3001627457-2019-00025 |
Device Sequence Number | 1 |
Product Code |
KRA
|
UDI-Device Identifier | 00858593006134 |
UDI-Public | 00858593006134 |
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 |
study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/21/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2022 |
Device Model Number | 500-55112 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/21/2019 |
Initial Date FDA Received | 09/17/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/21/2019 |
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 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 61 YR |