Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05

K-Number: K071367 · 2007-08-29

ApplicantLeMaitre Vascular, Inc.
Decision Date2007-08-29
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 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 2007-08-29 under 510(k) number K071367. 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 FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05?

FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 is a medical device that received FDA 510(k) clearance on 2007-08-29. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K071367.

When did FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 receive FDA 510(k) clearance?

FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 received FDA 510(k) clearance on 2007-08-29, under 510(k) number K071367.

Who is the listed applicant for FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05?

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 FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05?

The FDA product code for FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K212894PhasTIPPK183513XenoSure Dura Biologic PatchK173323AnastoClip GC Closure SystemK152833Pruitt F3-S Polyurethane Carotid ShuntK133026UNBALLOON NON-OCCLUSION MODELING CATHETERK132022LEMAITRE 8F OCCLUSION CATHETER

View all 29 devices →

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.

↑