0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
FDA 510(k) clearance K201286 · decided 2020-08-11
Clearance details
- K-number
- K201286
- Device name
- 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
- Applicant
- Nurse Assist, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-05-14
- Decision date
- 2020-08-11
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Haltom City, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRING recall (Z-0511-2024) | Nurse Assist, LLC | 2023-12-20 |
| 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 recall (Z-0512-2024) | Nurse Assist, LLC | 2023-12-20 |