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FDA 510(k)

Paragonix SherpaPak Cardiac Transport System

K-Number: K182735 · 2018-10-19

ApplicantParagonix Technologies
Decision Date2018-10-19
Product CodeMSB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Paragonix SherpaPak Cardiac Transport System is a medical device manufactured by Paragonix Technologies. It received FDA 510(k) clearance on 2018-10-19 under approval number K182735. 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 Paragonix SherpaPak Cardiac Transport System?

Paragonix SherpaPak Cardiac Transport System is a medical device that received FDA 510(k) clearance on 2018-10-19. It is manufactured by Paragonix Technologies. The 510(k) number is K182735.

When was Paragonix SherpaPak Cardiac Transport System approved by the FDA?

Paragonix SherpaPak Cardiac Transport System received FDA 510(k) clearance on 2018-10-19, under approval number K182735.

What company makes Paragonix SherpaPak Cardiac Transport System?

Paragonix SherpaPak Cardiac Transport System is manufactured by Paragonix Technologies.

What is the FDA product code for Paragonix SherpaPak Cardiac Transport System?

The FDA product code for Paragonix SherpaPak Cardiac Transport System is MSB.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT05855135 Assessment of Combined CCM and ICD Device in HFrEF ACTIVE_NOT_RECRUITING NCT06164808 Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch RECRUITING NCT07232030 Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 40415770 Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory. REC, interventional cardiology (2024)

Other Devices by Paragonix Technologies

K191440Paragonix SherpaPak Pancreas Transport System K201048SherpaPak Pediatric Liver Transport System K223874BAROguard K234060KIDNEYvault Portable Renal Perfusion System

Related Devices (Code: MSB)

K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. K190063Servator C SALF SolutionS.A.L.F. Spa K211314OCS Lung SolutionTransMedics, Inc. K222535OCS Lung Donor Flush SetTransMedics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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