510(k) K172410 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
| Applicant | Smiths Medical Asd, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 1, 2018 |
| Received | Aug 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172410
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2020 | Smiths Medical ASD Inc. smiths medical portex Loss of Resistance Device, REF 100/398/000 Terminated |
BSP | None listed |
| Feb 28, 2020 | Smiths Medical ASD Inc. Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or colle Terminated |
CAZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.