The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter.
| Device ID | K200027 |
| 510k Number | K200027 |
| Device Name: | Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin, CN 214415 |
| Contact | Jianwei Pan |
| Correspondent | Diana Hong Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-06 |
| Decision Date | 2020-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20193489103219 | K200027 | 000 |
| 20197344041975 | K200027 | 000 |
| 30193489189654 | K200027 | 000 |
| 20850037100730 | K200027 | 000 |
| 20850037100747 | K200027 | 000 |
| 30885632401316 | K200027 | 000 |
| 20885632401326 | K200027 | 000 |
| 20885632401333 | K200027 | 000 |
| 20885632401357 | K200027 | 000 |
| 20885632401364 | K200027 | 000 |
| 20197344039255 | K200027 | 000 |