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FDA 510(k)

BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM

K-Number: K090759 · 2009-04-01

ApplicantBiodrain Medical, Inc.
Decision Date2009-04-01
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biodrain Medical, Inc.. It received FDA 510(k) clearance on 2009-04-01 under 510(k) number K090759. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM?

BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-01. The listed applicant is Biodrain Medical, Inc.. The 510(k) number is K090759.

When did BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM receive FDA 510(k) clearance?

BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance on 2009-04-01, under 510(k) number K090759.

Who is the listed applicant for BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM?

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

What is the FDA product code for BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM?

The FDA product code for BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM is JCX.

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Related Devices (Code: JCX)

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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