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FDA 510(k)

Smart External Drain (SED) System

K-Number: K172759 · 2017-11-14

ApplicantAqueduct Critical Care, Inc.
Decision Date2017-11-14
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Smart External Drain (SED) System is the device name listed in this FDA 510(k) record. The listed applicant is Aqueduct Critical Care, Inc.. It received FDA 510(k) clearance on 2017-11-14 under 510(k) number K172759. 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 2017-11-14. The listed applicant is Aqueduct Critical Care, Inc.. The 510(k) number is K172759.

When did Smart External Drain (SED) System receive FDA 510(k) clearance?

Smart External Drain (SED) System received FDA 510(k) clearance on 2017-11-14, under 510(k) number K172759.

Who is the listed applicant for Smart External Drain (SED) System?

The FDA 510(k) record lists Aqueduct Critical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Aqueduct Critical Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181301Smart External Drain (SED) SystemK171586Smart External Drain (SED) SystemK161605Smart External Drain (SED) System

Related Devices (Code: JXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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