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FDA 510(k)

LEMAITRE 8F OCCLUSION CATHETER

K-Number: K132022 · 2013-11-06

ApplicantLeMaitre Vascular, Inc.
Decision Date2013-11-06
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE 8F OCCLUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2013-11-06 under 510(k) number K132022. 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 8F OCCLUSION CATHETER?

LEMAITRE 8F OCCLUSION CATHETER is a medical device that received FDA 510(k) clearance on 2013-11-06. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K132022.

When did LEMAITRE 8F OCCLUSION CATHETER receive FDA 510(k) clearance?

LEMAITRE 8F OCCLUSION CATHETER received FDA 510(k) clearance on 2013-11-06, under 510(k) number K132022.

Who is the listed applicant for LEMAITRE 8F OCCLUSION CATHETER?

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

What is the FDA product code for LEMAITRE 8F OCCLUSION CATHETER?

The FDA product code for LEMAITRE 8F OCCLUSION CATHETER is MJN.

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Other records listing LeMaitre Vascular, 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.

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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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