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FDA 510(k)

CATHWRITER(TM)

K-Number: K914105 · 1992-02-26

ApplicantSoftheart, Inc.
Decision Date1992-02-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHWRITER(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Softheart, Inc.. It received FDA 510(k) clearance on 1992-02-26 under 510(k) number K914105. 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 CATHWRITER(TM)?

CATHWRITER(TM) is a medical device that received FDA 510(k) clearance on 1992-02-26. The listed applicant is Softheart, Inc.. The 510(k) number is K914105.

When did CATHWRITER(TM) receive FDA 510(k) clearance?

CATHWRITER(TM) received FDA 510(k) clearance on 1992-02-26, under 510(k) number K914105.

Who is the listed applicant for CATHWRITER(TM)?

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

What is the FDA product code for CATHWRITER(TM)?

The FDA product code for CATHWRITER(TM) is DQK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Softheart, 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.

K930639ON-LINE ANALYSIS SYSTEMK921216OFF-LINE ANALYSIS SYSTEM

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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