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FDA 510(k)

LMI IRRIGATION CATHETER (IGR)

K-Number: K972623 · 1997-11-19

ApplicantLucas Medical, Inc.
Decision Date1997-11-19
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LMI IRRIGATION CATHETER (IGR) 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 1997-11-19 under 510(k) number K972623. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LMI IRRIGATION CATHETER (IGR)?

LMI IRRIGATION CATHETER (IGR) is a medical device that received FDA 510(k) clearance on 1997-11-19. The listed applicant is Lucas Medical, Inc.. The 510(k) number is K972623.

When did LMI IRRIGATION CATHETER (IGR) receive FDA 510(k) clearance?

LMI IRRIGATION CATHETER (IGR) received FDA 510(k) clearance on 1997-11-19, under 510(k) number K972623.

Who is the listed applicant for LMI IRRIGATION CATHETER (IGR)?

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 IRRIGATION CATHETER (IGR)?

The FDA product code for LMI IRRIGATION CATHETER (IGR) is DXE.

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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-SBK970657LMI THROMBECTOMY CATHETERK955126LMI BILIARY CATHETERK954760LMI ARTERIAL EMBOLECTOMY CATHETERK955125LMI OCCLUSION CATHETERK955499LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER

View all 7 devices →

Related Devices (Code: DXE)

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.

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLCK241330Fogarty Fortis Arterial Embolectomy CatheterEdwards LifesciencesK233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards LifesciencesK233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLCK233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards LifesciencesK213771Merlin Aspiration SystemMivi Neurovascular, 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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