510(k) K201286 ยท NGT Saline, Vascular Access Flush
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, Haltom City TX, US |
| Decision | Substantially Equivalent, Aug 11, 2020 |
| Received | May 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201286
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-B Open, Classified |
NGT | None listed |
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 Open, Classified |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.