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

Guidant Corp. — Predicate Candidate Screening

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

33 daysmedian FDA review time

90 days90th percentile

71clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061865	FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05	Guidant Corp.	2006-07-27	24	0
K061453	HI-TORQUE WHISPER VIEW GUIDE WIRE	Guidant Corp.	2006-06-22	28	0
K042908	RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM	Guidant Corp.	2004-11-12	22	0
K042218	ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTEC	Guidant Corp.	2004-08-31	26	0
K033834	OMNILINK .018 BILIARY STENT SYSTEM	Guidant Corp.	2004-01-02	23	1
K033393	ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM	Guidant Corp.	2003-11-10	18	5
K031678	HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROP	Guidant Corp.	2003-08-26	88	0
K031459	RAPIDO CUT-AWAY CUTTER	Guidant Corp.	2003-07-23	76	1
K031398	IS-1 HEMOSTASIS VALVE, MODEL 6799	Guidant Corp.	2003-05-20	15	0
K030512	GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM	Guidant Corp.	2003-05-14	84	1
K030019	MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE	Guidant Corp.	2003-01-24	21	0
K023320	AGILTRAC .035 PERIPHERAL DILATATION CATHETER	Guidant Corp.	2002-12-10	67	0
K023627	ESSEX ENDOSCOPE, MODEL SXD-1000	Guidant Corp.	2002-11-12	15	0
K023300	HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPE	Guidant Corp.	2002-10-28	25	0
K022738	AGILTRAC .035 PERIPHERAL DILATATION CATHETER	Guidant Corp.	2002-09-13	25	0
K022880	GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500	Guidant Corp.	2002-09-13	14	1
K021455	RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATH	Guidant Corp.	2002-08-02	88	18
K021824	DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 10	Guidant Corp.	2002-07-02	28	0
K021228	HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT	Guidant Corp.	2002-05-15	27	0
K021282	LV-1 HEMOSTASIS VALVE, MODEL #6789	Guidant Corp.	2002-05-02	14	0
K021283	GUIDANT BALLOON CATHETER, SEVERAL MODELS	Guidant Corp.	2002-05-02	14	0
K021284	EASYTRAK GUIDING CATHETER	Guidant Corp.	2002-05-02	14	17
K021285	HI-TORQUE EXTRA S'PORT GUIDEWIRE	Guidant Corp.	2002-05-02	14	0
K020340	MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH	Guidant Corp.	2002-03-01	28	0
K020161	AGILTRAC .018 PERIPHERAL DILATATION CATHETER	Guidant Corp.	2002-02-22	36	0
K014184	MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT S	Guidant Corp.	2002-01-18	29	0
K013833	HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDR	Guidant Corp.	2002-01-16	58	0
K014250	7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-111	Guidant Corp.	2002-01-10	15	0
K014007	DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM	Guidant Corp.	2002-01-07	33	0
K013092	HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPH	Guidant Corp.	2001-12-13	87	0
K013638	MODIFICATION TO VIKING OPTIMA GUIDING CATHETER	Guidant Corp.	2001-12-04	29	0
K012050	VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER	Guidant Corp.	2001-09-06	66	0
K012002	VIKING OPTIMA GUIDING CATHETER	Guidant Corp.	2001-07-26	29	0
K011881	DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM	Guidant Corp.	2001-07-18	30	0
K011506	OMNILINK .035 BILIARY STENT SYSTEM	Guidant Corp.	2001-06-15	30	1
K010831	AVIATOR PERIPHERAL DILATATION CATHETER	Guidant Corp.	2001-06-13	85	0
K011039	OMNILINK .018 BILIARY STENT SYSTEM	Guidant Corp.	2001-05-08	33	1
K010684	RX HERCULINK PLUS BILIARY STENT SYSTEM	Guidant Corp.	2001-04-12	35	0
K002143	DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM	Guidant Corp.	2000-10-12	87	0
K002206	HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC C	Guidant Corp.	2000-08-24	34	0
K001435	VIKING OPTIMA GUIDING CATHETER	Guidant Corp.	2000-06-02	25	0
K001224	RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 100	Guidant Corp.	2000-05-17	30	0
K001222	OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1	Guidant Corp.	2000-05-17	30	0
K000793	1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER	Guidant Corp.	2000-04-12	30	0
K000598	5F GUIDING CATHETER	Guidant Corp.	2000-03-24	30	0
K000101	RX VIATRAC 14 PERIPHERAL DILATATION CATHETER	Guidant Corp.	2000-02-10	28	0
K993639	RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18	Guidant Corp.	2000-01-27	91	0
K993588	MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS	Guidant Corp.	1999-11-17	26	0
K992863	LEAD STYLET,MODELS 6505,6506,6507,6508	Guidant Corp.	1999-11-12	79	0
K992319	RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIA	Guidant Corp.	1999-10-08	88	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