Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) 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 |
Applicant |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Applicant Contact |
Michael R. Johnson |
Correspondent |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Correspondent Contact |
Michael R. Johnson |
Regulation Number | 868.5150
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/09/2017 |
Decision Date | 06/01/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|