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FDA 510(k)

CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013

K-Number: K013523 · 2002-01-07

ApplicantShire Biologics, Inc.
Decision Date2002-01-07
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 is the device name listed in this FDA 510(k) record. The listed applicant is Shire Biologics, Inc.. It received FDA 510(k) clearance on 2002-01-07 under 510(k) number K013523. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013?

CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 is a medical device that received FDA 510(k) clearance on 2002-01-07. The listed applicant is Shire Biologics, Inc.. The 510(k) number is K013523.

When did CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 receive FDA 510(k) clearance?

CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 received FDA 510(k) clearance on 2002-01-07, under 510(k) number K013523.

Who is the listed applicant for CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013?

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

What is the FDA product code for CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013?

The FDA product code for CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 is LHI.

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Related Devices (Code: LHI)

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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