K214009 is an FDA 510(k) clearance for the D·Kaptain PTA High Pressure Balloon Dilatation Catheter. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Dk Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on April 5, 2023, 516 days after receiving the submission on November 5, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K214009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2021 |
| Decision Date | April 05, 2023 |
| Days to Decision | 516 days |
| Submission Type | Traditional |
| 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 |