The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Reinforced Epidural Catheter.
Device ID | K181782 |
510k Number | K181782 |
Device Name: | Medline Reinforced Epidural Catheter |
Classification | Catheter, Conduction, Anesthetic |
Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Contact | Claire Pigman |
Correspondent | Claire Pigman Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Product Code | BSO |
CFR Regulation Number | 868.5120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-03 |
Decision Date | 2019-03-04 |