Brand Name | STEEROCATH-DX BI-DIRECTIONAL STEERABLE DIAGNOSTIC CATHETERS |
Type of Device | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
Manufacturer (Section D) |
ARDEN HILLS, MN |
4100 hamline avenue |
st. paul MN 55112 |
|
Manufacturer (Section G) |
ARDEN HILLS, MN |
4100 hamline avenue |
|
st. paul MN 55112 |
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 6525486 |
MDR Text Key | 73831201 |
Report Number | 2134265-2017-04511 |
Device Sequence Number | 1 |
Product Code |
DRF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K924109 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
04/19/2017 |
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 Model Number | UNK409 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/19/2017
|
Initial Date FDA Received | 04/27/2017 |
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 |
|
|