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FDA 510(k)

LEMAITRE BALLOON CATHETER WITH IRRIGATION

K-Number: K992940 · 2000-02-22

ApplicantVascutech, Inc.
Decision Date2000-02-22
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE BALLOON CATHETER WITH IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Vascutech, Inc.. It received FDA 510(k) clearance on 2000-02-22 under 510(k) number K992940. 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 BALLOON CATHETER WITH IRRIGATION?

LEMAITRE BALLOON CATHETER WITH IRRIGATION is a medical device that received FDA 510(k) clearance on 2000-02-22. The listed applicant is Vascutech, Inc.. The 510(k) number is K992940.

When did LEMAITRE BALLOON CATHETER WITH IRRIGATION receive FDA 510(k) clearance?

LEMAITRE BALLOON CATHETER WITH IRRIGATION received FDA 510(k) clearance on 2000-02-22, under 510(k) number K992940.

Who is the listed applicant for LEMAITRE BALLOON CATHETER WITH IRRIGATION?

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 BALLOON CATHETER WITH IRRIGATION?

The FDA product code for LEMAITRE BALLOON CATHETER WITH IRRIGATION 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 CATHETERK992941LEMAITRE BILIARY CATHETERK992368LEMAITRE EMBOLECTOMY 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.

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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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