The following data is part of a premarket notification filed by Creganna Medical Also Doing Business As Ceganna Tactx Medica with the FDA for Attain Assist Cs Access Catheter.
| Device ID | K171819 |
| 510k Number | K171819 |
| Device Name: | Attain Assist CS Access Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Creganna Medical Also Doing Business As Ceganna Tactx Medica Parkmore West Galway, IE |
| Contact | Olivia Odhiambo |
| Correspondent | Olivia Odhiambo Creganna Medical Also Doing Business As Ceganna Tactx Medica 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 | 2017-06-19 |
| Decision Date | 2018-01-04 |
| Summary: | summary |