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FDA 510(k)

DUFLO CATHETER (HEPARIN COATED)

K-Number: K093847 · 2010-08-25

ApplicantThermopeutix, Inc.
Decision Date2010-08-25
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUFLO CATHETER (HEPARIN COATED) is the device name listed in this FDA 510(k) record. The listed applicant is Thermopeutix, Inc.. It received FDA 510(k) clearance on 2010-08-25 under 510(k) number K093847. 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 DUFLO CATHETER (HEPARIN COATED)?

DUFLO CATHETER (HEPARIN COATED) is a medical device that received FDA 510(k) clearance on 2010-08-25. The listed applicant is Thermopeutix, Inc.. The 510(k) number is K093847.

When did DUFLO CATHETER (HEPARIN COATED) receive FDA 510(k) clearance?

DUFLO CATHETER (HEPARIN COATED) received FDA 510(k) clearance on 2010-08-25, under 510(k) number K093847.

Who is the listed applicant for DUFLO CATHETER (HEPARIN COATED)?

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 DUFLO CATHETER (HEPARIN COATED)?

The FDA product code for DUFLO CATHETER (HEPARIN COATED) 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 CATHETERK080700DUOFLO CATHETER

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

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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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