K200027 is an FDA 510(k) clearance for the Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter. This device is classified as a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II - Special Controls, product code JKA).
Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on September 9, 2020, 247 days after receiving the submission on January 6, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 862.1675.
| 510(k) Number | K200027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2020 |
| Decision Date | September 09, 2020 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1675 |