Brand Name | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
Type of Device | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
Manufacturer (Section D) |
ATRICURE, INC. |
7555 innovation way |
mason OH 45040 |
|
Manufacturer (Section G) |
ATRICURE, INC. |
7555 innovation way |
|
mason OH 45040 |
|
Manufacturer Contact |
john
ehlert
|
7555 innovation way |
mason, OH 45040
|
5137554563
|
|
MDR Report Key | 9086912 |
MDR Text Key | 159515210 |
Report Number | 3011706110-2019-00043 |
Device Sequence Number | 1 |
Product Code |
FZP
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K122276 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/19/2019 |
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 | 01/01/2022 |
Device Model Number | PRO145 |
Device Catalogue Number | A000826-1 |
Device Lot Number | 90847 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/13/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/28/2019
|
Initial Date FDA Received | 09/19/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/08/2019 |
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 |