K220060 is an FDA 510(k) clearance for the Pre-filled Syringe with Saline. This device is classified as a Saline, Vascular Access Flush (Class II - Special Controls, product code NGT).
Submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on June 10, 2022, 151 days after receiving the submission on January 10, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200. Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use..
| 510(k) Number | K220060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2022 |
| Decision Date | June 10, 2022 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | NGT — Saline, Vascular Access Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |
| Definition | Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use. |