Sentreheart, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sentreheart, Inc.” (first 2006, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 | 1 | 30 |
| 2015 | 1 | 30 |
| 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 4 | 4 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
Review panels
Most recent Sentreheart, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153096 | LARIAT RS Suture Delivery Device | GAT | 2015-11-25 | 30 |
| K142241 | LARIAT sulture Delivery Device | GAT | 2014-09-12 | 30 |
| K090385 | LARIAT II SUTURE DELIVERY DEVICE | GAT | 2009-05-06 | 78 |
| K080364 | FINDRWIRZ GUIDE WIRE SYSTEM | DQX | 2008-08-11 | 182 |
| K070126 | OCCLUSION BALLOON CATHETER | DQY | 2008-02-08 | 388 |
| K060721 | LARIAT LOOP APPLICATOR | GAT | 2006-06-02 | 77 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-09-29.
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 Sentreheart, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Sentreheart, Inc.” (first 2006, latest 2015), across 3 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 Sentreheart, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sentreheart, Inc. is 78 days.
Which FDA product codes appear under Sentreheart, Inc.?
The most frequent FDA product codes under this applicant name are GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 4); DQX (Wire, Guide, Catheter, 1); DQY (Catheter, Percutaneous, 1).
Next steps
- See all 6 Sentreheart, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAT, Sentreheart, 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.