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

Abbott Vascular, Inc. — Predicate Candidate Screening

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

98 daysmedian FDA review time

261 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K142415	Hi-Torque JET Guide Wire Family	Abbott Vascular, Inc.	2014-12-19	113	0
K123067	PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY	Abbott Vascular, Inc.	2013-01-29	120	0
K122573	HI-TORQUE COMMAND GUIDE WIRE FAMILY	Abbott Vascular, Inc.	2012-11-20	89	0
K102705	ARMADA 14 PTA CATHETER	Abbott Vascular, Inc.	2010-12-07	78	0
K101648	HI-TORQUE WINN GUIDE WIRE FAMILY	Abbott Vascular, Inc.	2010-07-08	27	0
K101011	HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL	Abbott Vascular, Inc.	2010-05-24	42	0
K091825	HI-TORQUE PROGRESS GUIDE WIRE FAMILY	Abbott Vascular, Inc.	2009-09-25	98	0
K081417	FOXCROSS PTA CATHETER	Abbott Vascular, Inc.	2008-06-04	15	0
K080925	FOX PLUS PTA CATHETER	Abbott Vascular, Inc.	2008-04-28	26	0
K072460	HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE	Abbott Vascular, Inc.	2008-04-11	224	0
K063481	MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM	Abbott Vascular, Inc.	2007-09-14	301	0
K062554	STARCLOSE HEX-HUB DILATOR	Abbott Vascular, Inc.	2007-02-06	160	0
K060902	STARCLOSE INTRODUCER SET MODEL- 1002	Abbott Vascular, Inc.	2006-07-07	95	1
K032929	MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BI	Abbott Vascular, Inc.	2003-10-22	30	0
K031331	WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM	Abbott Vascular, Inc.	2003-08-12	106	0
K021062	CHITO-SEAL	Abbott Vascular, Inc.	2002-08-23	143	0
K014118	MODIFICATION TO SUPERCROSS CATHETER	Abbott Vascular, Inc.	2002-01-11	28	0
K013683	MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE	Abbott Vascular, Inc.	2001-12-06	29	0
K001856	SUPERCROSS CATHETER	Abbott Vascular, Inc.	2001-03-07	261	0
K001703	PERCLOSE VASCULAR SUTURE DELIVERY DEVICE	Abbott Vascular, Inc.	2000-10-03	120	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