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FDA 510(k)

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS

K-Number: K991594 · 1999-08-05

ApplicantSangstat Medical Corp.
Decision Date1999-08-05
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS is the device name listed in this FDA 510(k) record. The listed applicant is Sangstat Medical Corp.. It received FDA 510(k) clearance on 1999-08-05 under 510(k) number K991594. The device is classified under product code MSB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS?

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS is a medical device that received FDA 510(k) clearance on 1999-08-05. The listed applicant is Sangstat Medical Corp.. The 510(k) number is K991594.

When did CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS receive FDA 510(k) clearance?

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS received FDA 510(k) clearance on 1999-08-05, under 510(k) number K991594.

Who is the listed applicant for CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS?

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

What is the FDA product code for CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS?

The FDA product code for CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS is MSB.

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Other records listing Sangstat Medical Corp. as applicant

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Related Devices (Code: MSB)

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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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