Approval for the celt acd vascular closure device. This device is indicated for the percutaneous closure of common femoral artery puncture sites while reducing time-to-hemostasis in patients who have undergone diagnostic or interventional intra-arterial catheterization procedures where either 5f or 6f introducer sheaths have been used.
| Device | CELT ACD VASCULAR CLOSURE DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | VASORUM LTD |
| Date Received | 2015-02-03 |
| Decision Date | 2016-07-20 |
| Notice Date | 2016-07-25 |
| PMA | P150006 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 16m-2185 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | VASORUM LTD 2012 Orchard Ave citywest Business Campus dublin 24 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150006 | | Original Filing |
| S004 |
2019-08-13 |
30-day Notice |
| S003 | | |
| S002 | | |
| S001 |
2016-10-17 |
Normal 180 Day Track |
NIH GUDID Devices