Cardiva Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cardiva Medical, Inc.” (first 2004, latest 2013), plus 2 PMA decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 135 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 56 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXC | Clamp, Vascular | 7 | 7 |
| MGB | Device, Hemostasis, Vascular | 2 | 0 |
Review panels
- Cardiovascular (9)
Most recent Cardiva Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130124 | CATALYST II AND III | DXC | 2013-03-14 | 56 |
| K082930 | CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE | DXC | 2009-02-13 | 135 |
| K072297 | BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM | DXC | 2007-09-12 | 26 |
| K070485 | BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L | DXC | 2007-03-22 | 30 |
| K051817 | BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM | DXC | 2006-12-06 | 519 |
| K061075 | BOOMERANG WIRE | DXC | 2006-09-01 | 137 |
| K041486 | VASOSTASIS VASCULAR CLOSURE SYSTEM | DXC | 2004-10-22 | 140 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P120016 | PMA | VASCADE VASCULAR CLOSURE SYSTEM | 2013-01-31 |
| P080029 | PMA | QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM) | 2010-04-08 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiva Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Cardiva Medical, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04538781: AMBULATE VASCADE MVP Same Day Discharge Retrospective Registry (Completed, started 2020-10-09)
- NCT03573206: AMBULATE Continued Access Protocol to Evaluate the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) (Completed, started 2018-08-27)
- NCT03193021: AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID (Completed, started 2017-09-20)
- NCT02948257: VASCADE ANTEGRADE-PVD Post-Market Registry (Completed, started 2017-01-19)
- NCT01297322: RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT) (Completed, started 2011-09)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiva Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Cardiva Medical, Inc.” (first 2004, latest 2013), plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cardiva Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiva Medical, Inc. is 135 days.
Which FDA product codes appear under Cardiva Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXC (Clamp, Vascular, 7); MGB (Device, Hemostasis, Vascular, 2).
Next steps
- See all 7 Cardiva Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXC, Cardiva Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.