The following data is part of a premarket notification filed by Creganna Medical Aslo Business As Cregganna Tactx Medical with the FDA for Trapper Exchange Device.
| Device ID | K162253 |
| 510k Number | K162253 |
| Device Name: | Trapper Exchange Device |
| Classification | Catheter, Percutaneous |
| Applicant | CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL PARKMORE WEST Galway, IE |
| Contact | Orla Hickey |
| Correspondent | Orla Hickey CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL PARKMORE WEST Galway, IE |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-10 |
| Decision Date | 2017-01-06 |
| Summary: | summary |