Brand Name | ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL |
Manufacturer (Section D) |
ANGIOSCORE, INC |
5055 brandin court |
fremont CA 94538 |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
florie
cazem
|
5055 brandin court |
fremont, CA 94538
|
510933-792
|
|
MDR Report Key | 5336364 |
MDR Text Key | 35205430 |
Report Number | 3005462046-2015-00037 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K101735 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/07/2015 |
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 | 10/19/2018 |
Device Model Number | 2155-2540 |
Device Catalogue Number | 2155-2540 |
Device Lot Number | G15100031 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/15/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/16/2015
|
Initial Date FDA Received | 12/30/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/15/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/04/2015 |
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;
|
|
|