Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Medline Reinforced Epidural Catheter

K-Number: K181782 · 2019-03-04

ApplicantMedline Industries, Inc.
Decision Date2019-03-04
Product CodeBSO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Medline Reinforced Epidural Catheter is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2019-03-04 under approval number K181782. The device is classified under product code BSO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Reinforced Epidural Catheter?

Medline Reinforced Epidural Catheter is a medical device that received FDA 510(k) clearance on 2019-03-04. It is manufactured by Medline Industries, Inc.. The 510(k) number is K181782.

When was Medline Reinforced Epidural Catheter approved by the FDA?

Medline Reinforced Epidural Catheter received FDA 510(k) clearance on 2019-03-04, under approval number K181782.

What company makes Medline Reinforced Epidural Catheter?

Medline Reinforced Epidural Catheter is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Reinforced Epidural Catheter?

The FDA product code for Medline Reinforced Epidural Catheter is BSO.

Related Clinical Trials

NCT05606952 Color Doppler to Confirm Epidural Catheter Positioning in Parturient COMPLETED NCT06556836 "Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization" COMPLETED

Other Devices by Medline Industries, Inc.

K162829Medline UNITE® Ankle Fracture Plating System K160642Medline ENFit Syringe K161473Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) K152564Gemini Sterilization Wrap K161035Medline Singe Patient Use Blood Pressure Cuff K152458Gemini Bonded Sterilization Wrap

View all 75 devices →

Related Devices (Code: BSO)

K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health K153297Perifix and Contiplex CatheterB.Braun Medical, Inc. K152952E-CathPAJUNK GmbH Medizintechnologie K150731Medline Epidural CatheterMedline Industries, Inc. K150789SPINAUT-E, SPINAUT-IImedicom Co., Ltd. K171584B. Braun Tear-Away Introducer NeedleB.Braun Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑