The following data is part of a premarket notification filed by Jiangsu Micsafe Medical Technology Co., Ltd with the FDA for Blood Collection Needle For Single Use & Blood Collection Needle With Holder For Single Use, Safety Blood Collection Needle For Single Use, Safety Blood Collection Needle With Holder For Single Use, Blood Collection Set For Single Use & Safety Blood .
| Device ID | K212019 |
| 510k Number | K212019 |
| Device Name: | Blood Collection Needle For Single Use & Blood Collection Needle With Holder For Single Use, Safety Blood Collection Needle For Single Use, Safety Blood Collection Needle With Holder For Single Use, Blood Collection Set For Single Use & Safety Blood |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Jiangsu Micsafe Medical Technology Co., Ltd Xituan Industrial Park, Dafeng District Yancheng, CN 224125 |
| Contact | Tony Yang |
| Correspondent | Tony Yang Jiangsu Micsafe Medical Technology Co., Ltd Xituan Industrial Park, Dafeng District Yancheng, CN 224125 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26971911292564 | K212019 | 000 |
| 16971911291508 | K212019 | 000 |
| 16971911291515 | K212019 | 000 |
| 16971911291522 | K212019 | 000 |
| 16971911291546 | K212019 | 000 |
| 16971911291553 | K212019 | 000 |
| 16971911291560 | K212019 | 000 |
| 16971911291577 | K212019 | 000 |
| 16971911292529 | K212019 | 000 |
| 26971911292557 | K212019 | 000 |
| 16971911290778 | K212019 | 000 |