Flowcardia, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Flowcardia, Inc.” (first 2005, latest 2010), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 94 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 | 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 5 | 5 |
| PDU | Catheter For Crossing Total Occlusions | 3 | 3 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
Review panels
- Cardiovascular (10)
- General Hospital (1)
Most recent Flowcardia, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 | PDU | 2010-02-17 | 211 |
| K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 | DXT | 2009-06-19 | 102 |
| K091254 | THE CROSSER 14 OTW CATHETER, MODEL CRU014 | DQY | 2009-05-29 | 30 |
| K091119 | MODIFICATION TO THE CROSSER SYSTEM | PDU | 2009-05-15 | 28 |
| K080849 | MICROSHEATH LP AND LP-AT | DQY | 2008-07-25 | 121 |
| K080765 | CROSSER LP SYSTEM | DQX | 2008-06-20 | 94 |
| K073289 | MICROSHEATH XL CATHETERS | DQY | 2008-01-11 | 51 |
| K072776 | THE CROSSER SYSTEM | PDU | 2007-12-07 | 70 |
| K062868 | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 | DQY | 2007-01-19 | 116 |
| K051580 | VP SHEATH | DQY | 2005-10-31 | 138 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-01-09.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Flowcardia, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Flowcardia, Inc.” (first 2005, latest 2010), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Flowcardia, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Flowcardia, Inc. is 94 days.
Which FDA product codes appear under Flowcardia, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 5); PDU (Catheter For Crossing Total Occlusions, 3); DQX (Wire, Guide, Catheter, 2).
Next steps
- See all 11 Flowcardia, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Flowcardia, 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.