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FDA 510(k)

LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER

K-Number: K955499 · 1996-02-28

ApplicantLucas Medical, Inc.
Decision Date1996-02-28
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER is the device name listed in this FDA 510(k) record. The listed applicant is Lucas Medical, Inc.. It received FDA 510(k) clearance on 1996-02-28 under 510(k) number K955499. 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 LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER?

LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER is a medical device that received FDA 510(k) clearance on 1996-02-28. The listed applicant is Lucas Medical, Inc.. The 510(k) number is K955499.

When did LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER receive FDA 510(k) clearance?

LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER received FDA 510(k) clearance on 1996-02-28, under 510(k) number K955499.

Who is the listed applicant for LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER?

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

What is the FDA product code for LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER?

The FDA product code for LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER is MJN.

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Other records listing Lucas Medical, 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.

K983802LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SBK972623LMI IRRIGATION CATHETER (IGR)K970657LMI THROMBECTOMY CATHETERK955126LMI BILIARY CATHETERK954760LMI ARTERIAL EMBOLECTOMY CATHETERK955125LMI OCCLUSION 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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