Cardica, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Cardica, Inc.” (first 2005, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 | 0 | — |
| 2014 | 3 | 40 |
| 2015 | 0 | — |
| 2016 | 2 | 178 |
| 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 |
|---|---|---|---|
| FZP | Clip, Implantable | 10 | 10 |
| GDW | Staple, Implantable | 5 | 5 |
Review panels
Most recent Cardica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload | GDW | 2016-07-20 | 89 |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge | GDW | 2016-01-15 | 268 |
| K140118 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE | GDW | 2014-02-25 | 40 |
| K140170 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE | GDW | 2014-02-19 | 27 |
| K132581 | MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE | GDW | 2014-01-07 | 144 |
| K101018 | CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 | FZP | 2010-06-25 | 73 |
| K091017 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 | FZP | 2009-04-29 | 20 |
| K090872 | MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM | FZP | 2009-04-21 | 22 |
| K081225 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM | FZP | 2008-09-05 | 128 |
| K073304 | CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES | FZP | 2007-12-20 | 27 |
5 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-11-06.
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 Cardica, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01476761: MicroCutter in Surgical Stapling - European Trial I (Completed, started 2011-11)
- NCT01478061: Multi-center Assessment of Grafts in Coronaries: Long-term Evaluation of the C-Port Device (Completed, started 2009-04)
- NCT00355563: Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery (Completed, started 2006-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardica, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Cardica, Inc.” (first 2005, latest 2016), 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 Cardica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardica, Inc. is 40 days.
Which FDA product codes appear under Cardica, Inc.?
The most frequent FDA product codes under this applicant name are FZP (Clip, Implantable, 10); GDW (Staple, Implantable, 5).
Next steps
- See all 15 Cardica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FZP, Cardica, 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.