Submission Details
| 510(k) Number | K042061 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2004 |
| Decision Date | August 26, 2004 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Special
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
Aug 2004
Decision
24d
Days
Class 2
Risk
About This 510(k) Submission
K042061 is an FDA 510(k) clearance for the 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE, a Saline, Vascular Access Flush (Class II — Special Controls, product code NGT), submitted by Becton Dickinson (Franklin Lakes, US). The FDA issued a Cleared decision on August 26, 2004, 24 days after receiving the submission on August 2, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.
Device Classification
| 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. |
Manufacturer
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