Brand Name | SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER |
Type of Device | TURBO ELITE |
Manufacturer (Section D) |
SPECTRANETICS |
9965 federal drive |
colorado springs CO 80921 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
barbara
creel
|
9965 federal drive |
colorado springs, CO 80921
|
719447-246
|
|
MDR Report Key | 6527540 |
MDR Text Key | 74088107 |
Report Number | 1721279-2017-00073 |
Device Sequence Number | 1 |
Product Code |
MCW
|
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K170059 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/01/2005,04/06/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/27/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 03/14/2019 |
Device Model Number | 410-152 |
Device Catalogue Number | 410-152 |
Device Lot Number | FBD17C14A015 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/12/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/01/2005 |
Date Report to Manufacturer | 01/10/2005 |
Date Manufacturer Received | 07/08/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/14/2017 |
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 |
Treatment | SPECTRANETICS CVX-300 EXCIMER LASER |
Patient Outcome(s) |
Other;
|