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FDA 510(k)

DIALGUARD ENDOTOXIN REMOVAL DEVICE

K-Number: K993806 · 2000-08-14

ApplicantClarigen, Inc.
Decision Date2000-08-14
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALGUARD ENDOTOXIN REMOVAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Clarigen, Inc.. It received FDA 510(k) clearance on 2000-08-14 under 510(k) number K993806. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALGUARD ENDOTOXIN REMOVAL DEVICE?

DIALGUARD ENDOTOXIN REMOVAL DEVICE is a medical device that received FDA 510(k) clearance on 2000-08-14. The listed applicant is Clarigen, Inc.. The 510(k) number is K993806.

When did DIALGUARD ENDOTOXIN REMOVAL DEVICE receive FDA 510(k) clearance?

DIALGUARD ENDOTOXIN REMOVAL DEVICE received FDA 510(k) clearance on 2000-08-14, under 510(k) number K993806.

Who is the listed applicant for DIALGUARD ENDOTOXIN REMOVAL DEVICE?

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

What is the FDA product code for DIALGUARD ENDOTOXIN REMOVAL DEVICE?

The FDA product code for DIALGUARD ENDOTOXIN REMOVAL DEVICE is FIP.

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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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