K211044 is an FDA 510(k) clearance for the Sublime Radial Access 018 RX Dilatation Catheter. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, (Ballinasloe, IE). The FDA issued a Cleared decision on June 16, 2021, 69 days after receiving the submission on April 8, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K211044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2021 |
| Decision Date | June 16, 2021 |
| Days to Decision | 69 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |