K231754 is an FDA 510(k) clearance for the Praxiject™ 0.9% NaCl. This device is classified as a Saline, Vascular Access Flush (Class II - Special Controls, product code NGT).
Submitted by Medxl, Inc. (Pointe-Claire, CA). The FDA issued a Cleared decision on July 13, 2023, 28 days after receiving the submission on June 15, 2023.
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 | K231754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2023 |
| Decision Date | July 13, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |