The following data is part of a premarket notification filed by Shenzhen Shineyard Medical Device Co. Ltd. with the FDA for Matreneu Percutaneous Balloon Compression Kit.
| Device ID | K220920 |
| 510k Number | K220920 |
| Device Name: | Matreneu Percutaneous Balloon Compression Kit |
| Classification | Instrument, Surgical, Non-powered |
| Applicant | Shenzhen Shineyard Medical Device Co. Ltd. 3F, Changfeng Industrial Block No.3 Liuxian Road, Xin’an Bao’an District, Shenzhen, CN 518000 |
| Contact | Yan Ping |
| Correspondent | Joyce Yang Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, CN 518100 |
| Product Code | HAO |
| CFR Regulation Number | 882.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-30 |
| Decision Date | 2022-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939698601494 | K220920 | 000 |
| 06939698601340 | K220920 | 000 |
| 06939698601333 | K220920 | 000 |
| 06939698601326 | K220920 | 000 |
| 06939698601302 | K220920 | 000 |
| 06939698601296 | K220920 | 000 |
| 06939698601289 | K220920 | 000 |
| 06939698601272 | K220920 | 000 |
| 06939698601265 | K220920 | 000 |
| 06939698601258 | K220920 | 000 |
| 06939698601241 | K220920 | 000 |
| 06939698601357 | K220920 | 000 |
| 06939698601364 | K220920 | 000 |
| 06939698601388 | K220920 | 000 |
| 06939698601487 | K220920 | 000 |
| 06939698601470 | K220920 | 000 |
| 06939698601463 | K220920 | 000 |
| 06939698601456 | K220920 | 000 |
| 06939698601449 | K220920 | 000 |
| 06939698601432 | K220920 | 000 |
| 06939698601425 | K220920 | 000 |
| 06939698601418 | K220920 | 000 |
| 06939698601401 | K220920 | 000 |
| 06939698601395 | K220920 | 000 |
| 06939698601234 | K220920 | 000 |