The following data is part of a premarket notification filed by Sunny Medical Device (shenzhen) Co., Ltd. with the FDA for Sunmed Haemostatic Valves.
| Device ID | K153685 |
| 510k Number | K153685 |
| Device Name: | Sunmed Haemostatic Valves |
| Classification | Wire, Guide, Catheter |
| Applicant | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. 56 LEHIGH AISLE Irvine, CA 92612 |
| Contact | James Qi Zhang |
| Correspondent | James Qi Zhang SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. 56 LEHIGH AISLE Irvine, CA 92612 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-22 |
| Decision Date | 2016-10-13 |
| Summary: | summary |