The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for 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.
| Device ID | K172410 |
| 510k Number | K172410 |
| Device Name: | 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 |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Michael R. Johnson |
| Correspondent | Michael R. Johnson Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | BSP |
| Subsequent Product Code | BSN |
| Subsequent Product Code | CAZ |
| Subsequent Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-09 |
| Decision Date | 2018-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517078781 | K172410 | 000 |
| 35019517078767 | K172410 | 000 |
| 35019517078613 | K172410 | 000 |
| 35019517071416 | K172410 | 000 |
| 35019517071393 | K172410 | 000 |
| 35019517071386 | K172410 | 000 |
| 35019517071379 | K172410 | 000 |
| 35019517071362 | K172410 | 000 |
| 55019517054659 | K172410 | 000 |