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

Vascutech, Inc. · Predicate Candidate Screening

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

175 daysmedian FDA review time

226 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K001621	DARDIK CAROTID SHUNT	Vascutech, Inc.	2000-12-06	194	0
K992942	LEMAITRE OCCLUSION CATHETER	Vascutech, Inc.	2000-04-13	226	0
K992933	LEMAITRE IRRIGATION CATHETER	Vascutech, Inc.	2000-03-08	190	0
K992934	LEMAITRE VENOUS THROMBECTOMY CATHETER	Vascutech, Inc.	2000-03-01	183	0
K992940	LEMAITRE BALLOON CATHETER WITH IRRIGATION	Vascutech, Inc.	2000-02-22	175	0
K992941	LEMAITRE BILIARY CATHETER	Vascutech, Inc.	2000-01-12	134	0
K992368	LEMAITRE EMBOLECTOMY CATHETER	Vascutech, Inc.	1999-12-09	147	9
K980723	2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)	Vascutech, Inc.	1999-02-12	353	0
K946352	LEMAITRE VALVULOTOME II	Vascutech, Inc.	1995-06-21	173	0
K932009	THE SAMUELS RETROGRAD VALVULOTOME	Vascutech, Inc.	1993-09-21	151	0
K932184	STERILE LEMAITRE GLOW 'N TELL TAPE	Vascutech, Inc.	1993-07-22	78	6
K924171	LEMAITRE RETROGRADE VALVULOTOME	Vascutech, Inc.	1993-02-16	182	0
K912548	LEMAITRE-BOOKWALTER VESSEL DEVICES	Vascutech, Inc.	1991-09-18	100	0
K850394	LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR	Vascutech, Inc.	1985-04-24	82	0

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