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

Cordis Corp. — Predicate Candidate Screening

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

68 daysmedian FDA review time

202 days90th percentile

315clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K130981	FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE	Cordis Corp.	2014-03-12	337	0
K112797	POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	Cordis Corp.	2012-05-04	221	0
K101651	ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI	Cordis Corp.	2010-07-09	28	0
K082143	MICRO GUIDE CATHETER XP	Cordis Corp.	2008-08-25	26	0
K062798	SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB	Cordis Corp.	2008-02-06	505	2
K060877	PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1	Cordis Corp.	2006-04-27	27	0
K050645	CORDIS AMIIA .014 PTA BALLOON CATHETER	Cordis Corp.	2005-04-01	18	0
K040592	CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE	Cordis Corp.	2004-12-17	284	0
K042969	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BIL	Cordis Corp.	2004-11-08	11	2
K033394	CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO	Cordis Corp.	2003-12-22	60	0
K032137	PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corp.	2003-09-17	68	1
K032457	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BIL	Cordis Corp.	2003-09-04	24	0
K031777	MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC B	Cordis Corp.	2003-07-07	27	3
K031197	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BIL	Cordis Corp.	2003-06-16	61	0
K030409	SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM	Cordis Corp.	2003-03-10	31	0
K023907	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, C	Cordis Corp.	2002-12-18	23	0
K023217	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BIL	Cordis Corp.	2002-10-25	29	1
K023116	CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A,	Cordis Corp.	2002-10-18	29	0
K021898	SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corp.	2002-08-14	65	1
K021345	MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY S	Cordis Corp.	2002-06-28	60	0
K021593	MODIFICATION TO ENVOY AND VISTA BRITE TIP	Cordis Corp.	2002-06-13	29	2
K020809	MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY S	Cordis Corp.	2002-04-12	30	0
K020316	CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE	Cordis Corp.	2002-03-20	49	0
K020052	SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corp.	2002-02-11	34	0
K012993	MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY S	Cordis Corp.	2001-10-05	29	1
K012590	CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO	Cordis Corp.	2001-09-07	28	0
K010411	PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTE	Cordis Corp.	2001-08-27	196	1
K012087	CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT	Cordis Corp.	2001-08-01	29	0
K003920	CORDIS M3 PTA DILATATION CATHETER	Cordis Corp.	2001-06-15	178	0
K010083	TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MO	Cordis Corp.	2001-06-06	146	0
K010445	PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM	Cordis Corp.	2001-03-16	30	0
K003964	TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS	Cordis Corp.	2001-01-19	28	0
K003336	MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY	Cordis Corp.	2000-11-22	28	0
K003365	S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)	Cordis Corp.	2000-11-22	26	0
K003159	CORDIS SLALOM PTA BALLOON CATHETER	Cordis Corp.	2000-10-30	20	0
K001843	S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corp.	2000-07-18	29	0
K000062	CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION	Cordis Corp.	2000-07-07	179	0
K001135	6F & 7F INTRODUCING CATHETERS (MODIFICATION)	Cordis Corp.	2000-07-03	84	0
K001258	BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM	Cordis Corp.	2000-06-27	70	0
K000579	TEMPO AQUA ANGIOGRAPHIC CATHETER	Cordis Corp.	2000-05-03	71	0
K001136	CORDIS INTRODUCER GUIDE	Cordis Corp.	2000-04-28	18	1
K000753	CORDIS 13F CATHETER SHEATH INTRODUCER	Cordis Corp.	2000-04-06	29	0
K000715	ENVOY AND VISTA BRITE TIP	Cordis Corp.	2000-03-31	29	0
K000564	CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY	Cordis Corp.	2000-03-23	30	0
K993720	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER	Cordis Corp.	2000-01-18	76	0
K994358	ATW MARKER WIRE STEERABLE GUIDEWIRE	Cordis Corp.	2000-01-13	17	0
K994156	MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BIL	Cordis Corp.	2000-01-07	29	0
K994068	S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corp.	1999-12-23	21	0
K993646	S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	Cordis Corp.	1999-11-28	30	0
K993091	PALMAZ XL TANSHEPATIC BILIARY STENTS	Cordis Corp.	1999-10-29	43	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