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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LeMaitre Vascular, Inc. — Predicate Candidate Screening

32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

96 daysmedian FDA review time
209 days90th percentile
32clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212894PhasTIPPLeMaitre Vascular, Inc.2022-03-312020
K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc.2019-06-131770
K173323AnastoClip GC Closure SystemLeMaitre Vascular, Inc.2018-03-081390
K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc.2016-01-211140
K143454Pruitt F3-S Carotid ShuntLeMaitre Vascular, Inc.2015-08-272670
K142660Antegrade LeMills ValvulotomeLeMaitre Vascular, Inc.2014-10-17290
K1400421.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.2014-04-10920
K133026UNBALLOON NON-OCCLUSION MODELING CATHETERLeMaitre Vascular, Inc.2013-12-31960
K132022LEMAITRE 8F OCCLUSION CATHETERLeMaitre Vascular, Inc.2013-11-061280
K132047LEMILLS VALVULOTOMELeMaitre Vascular, Inc.2013-11-051260
K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVLeMaitre Vascular, Inc.2013-08-05210
K130016LIFESPAN EPTFE VASCULAR GRAFTLeMaitre Vascular, Inc.2013-02-05350
K123531UNBALLOON NON-OCCLUSIVE MODELING CATHETERLeMaitre Vascular, Inc.2012-12-14280
K121415MOLLRING MULTITASCLeMaitre Vascular, Inc.2012-09-051170
K121839UNBALLOON NON-OCCLUSIVE MODELING CATHETERLeMaitre Vascular, Inc.2012-08-08470
K110891THE UNBALLOON NON-OCCLUSIVE CATHETER; THE UNBALLOON NON-OCCLLeMaitre Vascular, Inc.2011-09-131670
K111884OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.2011-07-29280
K103080ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.2011-01-199217
K103356PRUITT CAROTID KITLeMaitre Vascular, Inc.2010-12-08220
K101740ALBOSURE POLYESTER VASCULAR PATCHLeMaitre Vascular, Inc.2010-09-20910
K091987ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-0LeMaitre Vascular, Inc.2010-04-232952
K093231ALBOGRAFT VASCULAR PROSTHESISLeMaitre Vascular, Inc.2010-01-149217
K081878LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYLeMaitre Vascular, Inc.2009-01-272090
K071367FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05LeMaitre Vascular, Inc.2007-08-291050
K051067PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOLeMaitre Vascular, Inc.2005-05-27311
K043023PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013LeMaitre Vascular, Inc.2004-12-03300
K033159LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 200LeMaitre Vascular, Inc.2003-12-19800
K032041DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)LeMaitre Vascular, Inc.2003-08-27570
K031282OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05LeMaitre Vascular, Inc.2003-08-051050
K021580OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, LeMaitre Vascular, Inc.2003-02-122740
K023688LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPERLeMaitre Vascular, Inc.2003-01-30900
K022145OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302LeMaitre Vascular, Inc.2003-01-1419610

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda