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FDA 510(k)

CorVista System® with PCWP Add-On

K-Number: K253576 · 2026-07-26

ApplicantAnalytics For Life, Inc.
Decision Date2026-07-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CorVista System® with PCWP Add-On is the device name listed in this FDA 510(k) record. The listed applicant is Analytics For Life, Inc.. It received FDA 510(k) clearance on 2026-07-26 under 510(k) number K253576. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorVista System® with PCWP Add-On?

CorVista System® with PCWP Add-On is a medical device that received FDA 510(k) clearance on 2026-07-26. The listed applicant is Analytics For Life, Inc.. The 510(k) number is K253576.

When did CorVista System® with PCWP Add-On receive FDA 510(k) clearance?

CorVista System® with PCWP Add-On received FDA 510(k) clearance on 2026-07-26, under 510(k) number K253576.

Who is the listed applicant for CorVista System® with PCWP Add-On?

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

What is the FDA product code for CorVista System® with PCWP Add-On?

The FDA product code for CorVista System® with PCWP Add-On is DQK.

Other records listing Analytics For Life, 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.

K233666CorVista System with PH Add-On

Related Devices (Code: DQK)

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.

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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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