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FDA 510(k)

Patient Assistant Model PA97000

K-Number: K190574 · 2019-09-24

ApplicantMedtronic, Inc.
Decision Date2019-09-24
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Assistant Model PA97000 is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2019-09-24 under approval number K190574. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Assistant Model PA97000?

Patient Assistant Model PA97000 is a medical device that received FDA 510(k) clearance on 2019-09-24. It is manufactured by Medtronic, Inc.. The 510(k) number is K190574.

When was Patient Assistant Model PA97000 approved by the FDA?

Patient Assistant Model PA97000 received FDA 510(k) clearance on 2019-09-24, under approval number K190574.

What company makes Patient Assistant Model PA97000?

Patient Assistant Model PA97000 is manufactured by Medtronic, Inc..

What is the FDA product code for Patient Assistant Model PA97000?

The FDA product code for Patient Assistant Model PA97000 is DSI.

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Related PubMed Literature

PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

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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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