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FDA 510(k)

LEMAITRE EMBOLECTOMY CATHETER

K-Number: K992368 · 1999-12-09

ApplicantVascutech, Inc.
Decision Date1999-12-09
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE EMBOLECTOMY 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 1999-12-09 under 510(k) number K992368. 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 LEMAITRE EMBOLECTOMY CATHETER?

LEMAITRE EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1999-12-09. The listed applicant is Vascutech, Inc.. The 510(k) number is K992368.

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

LEMAITRE EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1999-12-09, under 510(k) number K992368.

Who is the listed applicant for LEMAITRE EMBOLECTOMY 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 EMBOLECTOMY CATHETER?

The FDA product code for LEMAITRE EMBOLECTOMY CATHETER is DXE.

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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 SHUNTK992942LEMAITRE OCCLUSION CATHETERK992933LEMAITRE IRRIGATION CATHETERK992934LEMAITRE VENOUS THROMBECTOMY CATHETERK992940LEMAITRE BALLOON CATHETER WITH IRRIGATIONK992941LEMAITRE BILIARY CATHETER

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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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