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FDA 510(k)

LEMAITRE OCCLUSION CATHETER

K-Number: K992942 · 2000-04-13

ApplicantVascutech, Inc.
Decision Date2000-04-13
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE OCCLUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vascutech, Inc.. It received FDA 510(k) clearance on 2000-04-13 under 510(k) number K992942. 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 LEMAITRE OCCLUSION CATHETER?

LEMAITRE OCCLUSION CATHETER is a medical device that received FDA 510(k) clearance on 2000-04-13. The listed applicant is Vascutech, Inc.. The 510(k) number is K992942.

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

LEMAITRE OCCLUSION CATHETER received FDA 510(k) clearance on 2000-04-13, under 510(k) number K992942.

Who is the listed applicant for LEMAITRE OCCLUSION CATHETER?

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

What is the FDA product code for LEMAITRE OCCLUSION CATHETER?

The FDA product code for LEMAITRE OCCLUSION CATHETER is MJN.

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Other records listing Vascutech, 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.

K001621DARDIK CAROTID SHUNTK992933LEMAITRE IRRIGATION CATHETERK992934LEMAITRE VENOUS THROMBECTOMY CATHETERK992940LEMAITRE BALLOON CATHETER WITH IRRIGATIONK992941LEMAITRE BILIARY CATHETERK992368LEMAITRE EMBOLECTOMY CATHETER

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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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