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FDA 510(k)

DUOFLO CATHETER

K-Number: K080700 · 2008-09-26

ApplicantThermopeutix, Inc.
Decision Date2008-09-26
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUOFLO CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Thermopeutix, Inc.. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K080700. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUOFLO CATHETER?

DUOFLO CATHETER is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is Thermopeutix, Inc.. The 510(k) number is K080700.

When did DUOFLO CATHETER receive FDA 510(k) clearance?

DUOFLO CATHETER received FDA 510(k) clearance on 2008-09-26, under 510(k) number K080700.

Who is the listed applicant for DUOFLO CATHETER?

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

What is the FDA product code for DUOFLO CATHETER?

The FDA product code for DUOFLO CATHETER is MJN.

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.

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Other records listing Thermopeutix, 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.

K132701PRIMI SUPPORT CATHETERK130850PRIMI AND SECONDI SUPPORT CATHETERSK112219TAPAS CATHETERK093847DUFLO CATHETER (HEPARIN COATED)

Related Devices (Code: MJN)

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.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.

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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