Approval for the vascade¿ vascular closure system (vcs). This device is indicated for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who haveundergone diagnostic or interventional endovascular procedures using a 5f, 6f, or 7f procedural sheath. The vascade vcs is also indicated to reduce time to discharge eligibility in patients who have undergone diagnostic endovascular procedures using a 5f, 6f, or 7f procedural sheath.
| Device | VASCADE VASCULAR CLOSURE SYSTEM |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | CARDIVA MEDICAL, INC. |
| Date Received | 2012-08-03 |
| Decision Date | 2013-01-31 |
| Notice Date | 2013-05-17 |
| PMA | P120016 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 13M-0592 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIVA MEDICAL, INC. 2900 Lakeside Drive suite 160 santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P120016 | | Original Filing |
| S030 |
2022-10-11 |
30-day Notice |
| S029 | | |
| S028 |
2021-02-08 |
Normal 180 Day Track |
| S027 |
2019-07-08 |
Normal 180 Day Track |
| S026 |
2018-11-23 |
Normal 180 Day Track No User Fee |
| S025 |
2018-07-10 |
Real-time Process |
| S024 |
2018-05-30 |
Panel Track |
| S023 |
2017-03-20 |
30-day Notice |
| S022 |
2017-01-17 |
30-day Notice |
| S021 |
2016-11-04 |
Normal 180 Day Track |
| S020 |
2016-06-03 |
Real-time Process |
| S019 |
2016-01-07 |
30-day Notice |
| S018 |
2015-11-16 |
30-day Notice |
| S017 |
2015-11-03 |
135 Review Track For 30-day Notice |
| S016 |
2015-06-29 |
Special (immediate Track) |
| S015 |
2015-05-18 |
Real-time Process |
| S014 |
2015-04-03 |
Normal 180 Day Track No User Fee |
| S013 |
2015-03-12 |
30-day Notice |
| S012 |
2015-03-03 |
30-day Notice |
| S011 |
2015-02-25 |
30-day Notice |
| S010 |
2015-02-18 |
30-day Notice |
| S009 |
2015-02-09 |
30-day Notice |
| S008 |
2014-12-12 |
30-day Notice |
| S007 |
2014-10-20 |
30-day Notice |
| S006 |
2014-09-29 |
30-day Notice |
| S005 |
2014-08-18 |
135 Review Track For 30-day Notice |
| S004 |
2014-08-18 |
Real-time Process |
| S003 |
2014-06-27 |
30-day Notice |
| S002 |
2014-03-31 |
Real-time Process |
| S001 |
2014-03-18 |
30-day Notice |
NIH GUDID Devices