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)

Smart External Drain (SED) System

K-Number: K171586 · 2017-06-30

ApplicantAqueduct Critical Care, Inc.
Decision Date2017-06-30
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smart External Drain (SED) System is a medical device manufactured by Aqueduct Critical Care, Inc.. It received FDA 510(k) clearance on 2017-06-30 under approval number K171586. 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 Smart External Drain (SED) System?

Smart External Drain (SED) System is a medical device that received FDA 510(k) clearance on 2017-06-30. It is manufactured by Aqueduct Critical Care, Inc.. The 510(k) number is K171586.

When was Smart External Drain (SED) System approved by the FDA?

Smart External Drain (SED) System received FDA 510(k) clearance on 2017-06-30, under approval number K171586.

What company makes Smart External Drain (SED) System?

Smart External Drain (SED) System is manufactured by Aqueduct Critical Care, Inc..

What is the FDA product code for Smart External Drain (SED) System?

The FDA product code for Smart External Drain (SED) System is JXG.

Related Clinical Trials

NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07287124 A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults RECRUITING NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT06689553 Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure TERMINATED

Other Devices by Aqueduct Critical Care, Inc.

K161605Smart External Drain (SED) System K172759Smart External Drain (SED) System K181301Smart External Drain (SED) System

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.

↑