BERLIN HEART, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008454189 | 3008454189 | BERLIN HEART, INC. | 1 | Y | 2026-01-01 | 9391 Grogan's Mill Road Suite A-6 The Woodlands TX US 77380 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 137365 | 1419304766 | P160035 | EXCOR Pediatric Ventricular Assist Device | DSQ | 2017-06-06 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DSQ | 1 | 2017-06-06 |