CARDIOTEK BV
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008329188 | 3008329188 | CARDIOTEK BV | 1 | N | 2026-01-01 | Dr. Nolenslaan 107B GL SIttard Limburg NL 6136 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 180410 | 1958051147 | K183266 | EP-TRACER System | DQK | 2019-03-01 |
| 180410 | 1861592771 | K161245 | EP-TRACER System | DQK | 2016-08-05 |
| 180410 | 1441818944 | K134044 | EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM | DQK | 2014-03-31 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DQK | 3 | 2019-03-01 |