K220920 is an FDA 510(k) clearance for the Matreneu Percutaneous Balloon Compression Kit. This device is classified as a Instrument, Surgical, Non-powered (Class I - General Controls, product code HAO).
Submitted by Shenzhen Shineyard Medical Device Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2022, 161 days after receiving the submission on March 30, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4535.
| 510(k) Number | K220920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2022 |
| Decision Date | September 07, 2022 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAO - Instrument, Surgical, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4535 |