0.9% Sodium Chloride Injection, USP— 510(k) K173348
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K173348 for 0.9% Sodium Chloride Injection, USP, Substantially Equivalent on 2018-06-21. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code NGT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
Recent devices under product code NGT
view all- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K233623 — Praxiject SP 0.9% NaCl
- K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)
- K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- K223584 — Pre-Filled Normal Saline Flush Syringe
More clearances from Medline Industries, Inc.
view all- DEN210049 — Medline ART Skin Harvesting System
- K230559 — Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Adverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K173348
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173348.
Data sourced from openFDA. This site is unofficial and independent of the FDA.