Brand Name | DELTAPLUSH - CERECYTE MICROCOIL |
Type of Device | CNV DCS COILS |
Manufacturer (Section D) |
MICRUS ENDOVASCULAR, LLC |
821 fox lane |
san jose CA 95131 |
|
Manufacturer (Section G) |
CODMAN AND SHURTLEFF, INC (SAN JOSE) |
821 fox lane |
|
san jose CA 95131 |
|
Manufacturer Contact |
duane
durbin
|
miami lakes, FL 33014
|
5088283106
|
|
MDR Report Key | 4067302 |
MDR Text Key | 4857596 |
Report Number | 1226348-2014-00407 |
Device Sequence Number | 1 |
Product Code |
HCG
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K083646 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/23/2011 |
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 | 03/07/2016 |
Device Catalogue Number | CPL10015330 |
Device Lot Number | G13147 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/23/2011
|
Initial Date FDA Received | 09/08/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2011 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Treatment | UNK MICROCATHETER |
|
|