The following data is part of a premarket notification filed by Creagh Medical Ltd. (a Wholly Owned Subsidiary Of Surmodics, with the FDA for Sublime Radial Access 018 Rx Dilatation Catheter.
| Device ID | K211044 |
| 510k Number | K211044 |
| Device Name: | Sublime Radial Access 018 RX Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Creagh Medical Ltd. (a Wholly Owned Subsidiary Of Surmodics, Inc) IDA Business Park Ballinasloe, IE H53 Hy09 |
| Contact | Holly Ramirez |
| Correspondent | Holly Ramirez Creagh Medical Ltd. (a Wholly Owned Subsidiary Of Surmodics, Inc) IDA Business Park Ballinasloe, IE H53 Hy09 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-08 |
| Decision Date | 2021-06-16 |