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FDA 510(k)

TECHDEVICE OCCLUSION BALLOON CATHETER

K-Number: K051137 · 2006-02-24

ApplicantTechdevice Corporation
Decision Date2006-02-24
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TECHDEVICE OCCLUSION BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Techdevice Corporation. It received FDA 510(k) clearance on 2006-02-24 under 510(k) number K051137. 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 TECHDEVICE OCCLUSION BALLOON CATHETER?

TECHDEVICE OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2006-02-24. The listed applicant is Techdevice Corporation. The 510(k) number is K051137.

When did TECHDEVICE OCCLUSION BALLOON CATHETER receive FDA 510(k) clearance?

TECHDEVICE OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 2006-02-24, under 510(k) number K051137.

Who is the listed applicant for TECHDEVICE OCCLUSION BALLOON CATHETER?

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

What is the FDA product code for TECHDEVICE OCCLUSION BALLOON CATHETER?

The FDA product code for TECHDEVICE OCCLUSION BALLOON 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 Techdevice Corporation 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.

K110241ENDOLOGIX GUIDEWIREK053251TECHDEVICE GUIDEWIREK053028TECHDEVICE GUIDEWIRE

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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