Berlin Heart, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Berlin Heart, Inc.”, plus 1 PMA 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 |
|---|---|---|---|
| DSQ | Ventricular (Assist) Bypass | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P160035 | PMA | EXCOR Pediatric Ventricular Assist Device | 2017-06-06 |
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2026-04-24.
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 Berlin Heart, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05610787: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study (Enrolling by invitation, started 2022-11-14)
- NCT04782232: Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart (Recruiting, started 2021-06-01)
- NCT04634708: The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support (Completed, started 2020-11-01)
- NCT00583661: Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device (Completed, started 2007-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Berlin Heart, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Berlin Heart, Inc.”, plus 1 PMA 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 Berlin Heart, Inc.?
The most frequent FDA product codes under this applicant name are DSQ (Ventricular (Assist) Bypass, 1).
Next steps
- See all 0 Berlin Heart, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSQ, Berlin Heart, 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.