Hjarta Care, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Hjarta Care, LLC”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SHR | Device For Open Surgical Explant Of Endovascular Prostheses | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN250033 | De Novo | Device For Open Surgical Explant Of Endovascular Prostheses | 2026-04-17 |
Recalls
openFDA lists no recalls under a recalling firm named Hjarta Care, LLC.
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 Hjarta Care, LLC?
FDA lists 0 510(k) clearances under the applicant name “Hjarta Care, LLC”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Hjarta Care, LLC?
The most frequent FDA product codes under this applicant name are SHR (Device For Open Surgical Explant Of Endovascular Prostheses, 1).
Next steps
- See all 0 Hjarta Care, LLC clearances with predicates and recalls
- Run predicate analysis for product code SHR, Hjarta Care, LLC'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.