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)

SureFlo EVD Catheter

K-Number: K170599 · 2017-08-31

ApplicantArkis Biosciences, Inc.
Decision Date2017-08-31
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SureFlo EVD Catheter is a medical device manufactured by Arkis Biosciences, Inc.. It received FDA 510(k) clearance on 2017-08-31 under approval number K170599. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureFlo EVD Catheter?

SureFlo EVD Catheter is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Arkis Biosciences, Inc.. The 510(k) number is K170599.

When was SureFlo EVD Catheter approved by the FDA?

SureFlo EVD Catheter received FDA 510(k) clearance on 2017-08-31, under approval number K170599.

What company makes SureFlo EVD Catheter?

SureFlo EVD Catheter is manufactured by Arkis Biosciences, Inc..

What is the FDA product code for SureFlo EVD Catheter?

The FDA product code for SureFlo EVD Catheter is JXG.

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

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.

↑