K192414 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 February 13, 2020, 162 days after receiving the submission on September 4, 2019.
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 | K192414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2019 |
| Decision Date | February 13, 2020 |
| Days to Decision | 162 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. |