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FDA 510(k)

THE DART

K-Number: K905549 · 1991-02-19

ApplicantDexide, Inc.
Decision Date1991-02-19
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE DART is the device name listed in this FDA 510(k) record. The listed applicant is Dexide, Inc.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K905549. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DART?

THE DART is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Dexide, Inc.. The 510(k) number is K905549.

When did THE DART receive FDA 510(k) clearance?

THE DART received FDA 510(k) clearance on 1991-02-19, under 510(k) number K905549.

Who is the listed applicant for THE DART?

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

What is the FDA product code for THE DART?

The FDA product code for THE DART is HIF.

Other records listing Dexide, Inc. as applicant

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Related Devices (Code: HIF)

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.

K260209ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KGK252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation

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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