K221339 is an FDA 510(k) clearance for the Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Contego Medical, Inc. (Raleigh, US). The FDA issued a Cleared decision on June 9, 2022, 31 days after receiving the submission on May 9, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K221339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2022 |
| Decision Date | June 09, 2022 |
| Days to Decision | 31 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 |