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Lemaitre Vascular Straight Carotid Shunt (2002-01 +7 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K033159

by LeMaitre Vascular, Inc.

Identifiers

510(k) Number
K033159 FDA 510(k)
FDA Product Code
MJN FDA 510(k)
Models / Variants
2002-01 FDA 510(k)
2002-05 FDA 510(k)
2003-01 FDA 510(k)
2003-05 FDA 510(k)
2004-01 FDA 510(k)
2004-05 FDA 510(k)
2005-01 FDA 510(k)
2005-05 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4450 FDA 510(k)
Regulation Number
870.4450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Lemaitre Vascular Straight Carotid Shunt (2002-01 +7 more) by LeMaitre Vascular, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
LeMaitre Vascular, Inc.

Sources (1)

  • FDA 510(k) K033159 24 fields · synced Jun 18, 2026