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FDA 510(k)

VENDYS MODEL 5000 B/BC

K-Number: K060980 · 2007-08-16

ApplicantEndothelix, Inc.
Decision Date2007-08-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENDYS MODEL 5000 B/BC is the device name listed in this FDA 510(k) record. The listed applicant is Endothelix, Inc.. It received FDA 510(k) clearance on 2007-08-16 under 510(k) number K060980. 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 VENDYS MODEL 5000 B/BC?

VENDYS MODEL 5000 B/BC is a medical device that received FDA 510(k) clearance on 2007-08-16. The listed applicant is Endothelix, Inc.. The 510(k) number is K060980.

When did VENDYS MODEL 5000 B/BC receive FDA 510(k) clearance?

VENDYS MODEL 5000 B/BC received FDA 510(k) clearance on 2007-08-16, under 510(k) number K060980.

Who is the listed applicant for VENDYS MODEL 5000 B/BC?

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

What is the FDA product code for VENDYS MODEL 5000 B/BC?

The FDA product code for VENDYS MODEL 5000 B/BC 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 Endothelix, 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.

K072919VENDYS, MODEL 6000 B B/C

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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