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FDA 510(k)

LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM

K-Number: K081878 · 2009-01-27

ApplicantLeMaitre Vascular, Inc.
Decision Date2009-01-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM 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 2009-01-27 under 510(k) number K081878. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM?

LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-27. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K081878.

When did LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM receive FDA 510(k) clearance?

LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM received FDA 510(k) clearance on 2009-01-27, under 510(k) number K081878.

Who is the listed applicant for LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM?

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 LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM?

The FDA product code for LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM is DQY.

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Related Devices (Code: DQY)

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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