The following data is part of a premarket notification filed by Creganna Medical Aslo Business As Cregganna Tactx Medical with the FDA for Gore Tips Set, Gore Tips Sheath, Gore Tips Needle.
| Device ID | K152913 |
| 510k Number | K152913 |
| Device Name: | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-02 |
| Decision Date | 2016-07-21 |
| Summary: | summary |