FDA 510(k)

Cardiovascular Suite 4.2.1

K-Number: K202094 · 2022-01-11

Decision Date2022-01-11

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Cardiovascular Suite 4.2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Quipu S.R.L. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K202094. 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 Cardiovascular Suite 4.2.1?

Cardiovascular Suite 4.2.1 is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Quipu S.R.L. The 510(k) number is K202094.

When did Cardiovascular Suite 4.2.1 receive FDA 510(k) clearance?

Cardiovascular Suite 4.2.1 received FDA 510(k) clearance on 2022-01-11, under 510(k) number K202094.

Who is the listed applicant for Cardiovascular Suite 4.2.1?

The FDA 510(k) record lists Quipu S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardiovascular Suite 4.2.1?

The FDA product code for Cardiovascular Suite 4.2.1 is DQK.

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC K253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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.