K202231 is an FDA 510(k) clearance for the JADE. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 10, 2020, 125 days after receiving the submission on August 7, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K202231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2020 |
| Decision Date | December 10, 2020 |
| Days to Decision | 125 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 |