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FDA 510(k)

SHERPA PAK CARDIAC TRANSPORT SYSTEM

K-Number: K123326 · 2013-02-06

ApplicantParagonix Technologies, Inc.
Decision Date2013-02-06
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHERPA PAK CARDIAC TRANSPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Paragonix Technologies, Inc.. It received FDA 510(k) clearance on 2013-02-06 under 510(k) number K123326. 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 SHERPA PAK CARDIAC TRANSPORT SYSTEM?

SHERPA PAK CARDIAC TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-06. The listed applicant is Paragonix Technologies, Inc.. The 510(k) number is K123326.

When did SHERPA PAK CARDIAC TRANSPORT SYSTEM receive FDA 510(k) clearance?

SHERPA PAK CARDIAC TRANSPORT SYSTEM received FDA 510(k) clearance on 2013-02-06, under 510(k) number K123326.

Who is the listed applicant for SHERPA PAK CARDIAC TRANSPORT SYSTEM?

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

What is the FDA product code for SHERPA PAK CARDIAC TRANSPORT SYSTEM?

The FDA product code for SHERPA PAK CARDIAC TRANSPORT SYSTEM is MSB.

Related Clinical Trials

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Other records listing Paragonix Technologies, 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.

K254305BAROguard Donor Lung Preservation SystemK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System

Related Devices (Code: MSB)

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.

K261913X°Port Heart Preservation SystemTraferox Technologies, Inc.K222535OCS Lung Donor Flush SetTransMedics, Inc.K211314OCS Lung SolutionTransMedics, Inc.K190063Servator C SALF SolutionS.A.L.F. SpaK182735Paragonix SherpaPak Cardiac Transport SystemParagonix TechnologiesK180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc.

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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