The following data is part of a premarket notification filed by Creganna-tactx Medical with the FDA for Creganna Tactx Lotus Introducer Set (small), Creganna Tactx Lotus Introducer Set (large).
| Device ID | K140338 |
| 510k Number | K140338 |
| Device Name: | CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) |
| Classification | Introducer, Catheter |
| Applicant | CREGANNA-TACTX MEDICAL PARKMORE WEST Galway, IE Ireland |
| Contact | Niall Fox |
| Correspondent | Niall Fox CREGANNA-TACTX MEDICAL PARKMORE WEST Galway, IE Ireland |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-08-27 |
| Summary: | summary |