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FDA 510(k)

INSUFLOW DEWHEART

K-Number: K091366 · 2009-09-03

ApplicantLexion Medical, LLC
Decision Date2009-09-03
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSUFLOW DEWHEART is the device name listed in this FDA 510(k) record. The listed applicant is Lexion Medical, LLC. It received FDA 510(k) clearance on 2009-09-03 under 510(k) number K091366. 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 INSUFLOW DEWHEART?

INSUFLOW DEWHEART is a medical device that received FDA 510(k) clearance on 2009-09-03. The listed applicant is Lexion Medical, LLC. The 510(k) number is K091366.

When did INSUFLOW DEWHEART receive FDA 510(k) clearance?

INSUFLOW DEWHEART received FDA 510(k) clearance on 2009-09-03, under 510(k) number K091366.

Who is the listed applicant for INSUFLOW DEWHEART?

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

What is the FDA product code for INSUFLOW DEWHEART?

The FDA product code for INSUFLOW DEWHEART is HIF.

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Other records listing Lexion Medical, LLC 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.

K191780AP50/30 Insufflator with Insuflow PortK170799AP 50/30 Insufflator with Insuflow PortK132203PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULAK132204INSUFLOW SYNERGY XL PORTK120640INSUFLOW SYNERGY PORTK112357VESSEL GUARDIAN

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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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