Biocardia, Inc.: FDA clearances and approvals
Biocardia, Inc. has 6 FDA 510(k) clearances (first 2002, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time: 64 days. Since 2017 its median was 30 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 3 product recalls by a recalling firm named Biocardia, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov. It files with the SEC as BioCardia, Inc. (BCDA).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 26 |
| 2020 | 1 | 99 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Biocardia, Inc.'s cleared 510(k)s took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Biocardia, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242169 | Morph DNA Steerable Introducer Sheath | DYB | 2024-08-23 | 30 |
| K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | DQY | 2020-01-07 | 99 |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | DYB | 2019-05-06 | 26 |
| K090999 | BIOCARDIA MORPH SHEATH GUIDE | DYB | 2009-04-15 | 7 |
| K042553 | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER | DQY | 2005-02-17 | 150 |
| K012749 | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 | DQO | 2002-01-24 | 161 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-03-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Biocardia, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06258447: CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction (Recruiting, started 2024-08-01)
- NCT03455725: CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial (Active not recruiting, started 2021-06-30)
SEC filings
BioCardia, Inc. (BCDA): EDGAR filings, CIK 925741. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Biocardia, Inc. have?
Biocardia, Inc. has 6 FDA 510(k) clearances (first 2002, latest 2024), across 3 product codes in 1 review panel.
How long does FDA take to clear Biocardia, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biocardia, Inc.'s cleared 510(k)s is 64 days. Since 2017: 30 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Biocardia, Inc. make?
Its most frequent FDA product codes are DYB (Introducer, Catheter, 3); DQY (Catheter, Percutaneous, 2); DQO (Catheter, Intravascular, Diagnostic, 1).
Has Biocardia, Inc. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Biocardia, Inc; the most recent began 2014-03-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Biocardia, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Biocardia, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.